The Recall Desk

Archive

March 2015 recalls

559 recalls were announced in March 2015.

What the numbers show

Critical
102
Severe
148
High
245
Moderate
50
Low
14

Of the 559 recalls this month scored against our rubric, 18% are Critical, 26% are Severe.

401–500 of 559

  • SevereFDA (Food)·F-1236-2015·2015-03-04

    Elevated Chocolate Ice Cream Recalled for Listeria Contamination Risk

    Elevated Ice Cream Company is recalling chocolate ice cream due to potential Listeria monocytogenes contamination from recalled ice cream mix.

    Product
    Chocolate Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1266-2015·2015-03-04

    Elevated Mint Chip Ice Cream Recalled for Listeria Contamination Risk

    Elevated Ice Cream Company is recalling Mint Chip Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix supplier.

    Product
    Mint Chip Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1285-2015·2015-03-04

    Elevated Ice Cream Recalled for Potential Listeria Contamination

    Elevated Ice Cream Company is recalling SWORCH Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    SWORCH Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1355-2015·2015-03-04

    Lindt Chocolate Covered Almonds Recalled for Undeclared Hazelnuts

    Lindt & Sprungli USA is recalling specific lots of Milk Chocolate Covered Almonds because they may contain undeclared hazelnuts.

    Product
    Lindt Chocolate Specialties Milk Chocolate Covered Almonds,6.4 oz. packaged in a stand up bag (resealable pouch) Item Number: #8698 (or #8379)
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1278-2015·2015-03-04

    Elevated Rocky Road Ice Cream Recalled for Listeria Risk

    Elevated Ice Cream Company is recalling Rocky Road Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Rocky Road Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1137-2015·2015-03-04

    Invacare TDX Electric Wheelchairs Recalled for Fire Hazard

    Invacare is recalling 1,942 TDX, FDX, and Storm Series power wheelchairs because wire pinching can cause smoking, sparking, or fire.

    Product
    TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1332-2015·2015-03-04

    Adams Extract & Spice Recalls TBK Seasoning for Undeclared Peanut

    Adams Extract & Spice LLC is recalling TBK Seasoning 50# because it may contain undeclared peanut protein. The product was distributed in 24 states.

    Product
    TBK Seasoning 50# Item Code: 90280
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1246-2015·2015-03-04

    Elevated Cranberry Italian Ice Recalled for Listeria Risk

    Elevated Ice Cream Company is recalling Cranberry Italian Ice due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Cranberry Italian Ice. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1263-2015·2015-03-04

    Elevated Ice Cream Recalls Marionberry Italian Ice for Listeria Risk

    Elevated Ice Cream Company is recalling Marionberry Italian Ice due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Marionberry Italian Ice. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1229-2015·2015-03-04

    Elevated Ice Cream Recalled for Potential Listeria Contamination

    Elevated Ice Cream Company is recalling Black Current Italian Ice due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Black Current Italian Ice Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1075-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure

    Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Food)·F-1330-2015·2015-03-04

    Adams Extract & Spice Recalls BBQ Seasoning for Undeclared Peanut

    Adams Extract & Spice LLC is recalling Blacks BBQ Pinto Bean Seasoning #25 because it may contain undeclared peanut protein.

    Product
    Blacks BBQ Pinto Bean Seasoning #25 Item Code: 61155
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1226-2015·2015-03-04

    Elevated Ice Cream Recalled for Potential Listeria Contamination

    Elevated Ice Cream Company is recalling Amaretto Hazelnut Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Amaretto Hazelnut Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1366-2015·2015-03-04

    Queseria Bendita Recalls Requeson Soft Cheese Due to Listeria Risk

    Queseria Bendita is recalling Requeson, Latin Style Soft Cheese, because it may be contaminated with Listeria monocytogenes. The product was distributed in Oregon and Washington.

    Product
    Requeson, Latin Style Soft Cheese, packaged in a plastic tub, Net Wt. 1 lb. The UPC is 0 94922 10603 2.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1339-2015·2015-03-04

    Adams Taco Spice Pak Recalled for Undeclared Peanut Protein

    Adams Extract & Spice LLC is recalling CN Taco Spice Pak due to undeclared peanut protein. Consumers with peanut allergies should not consume the product.

    Product
    CN Taco Spice Pak 33.85# Item Code: J1301
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1227-2015·2015-03-04

    Elevated Apple Cider Italian Ice Recalled for Listeria Risk

    Elevated Ice Cream Company is recalling Apple Cider Italian Ice due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Apple Cider Italian Ice. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1269-2015·2015-03-04

    Elevated Ice Cream Recalled for Potential Listeria Contamination

    Elevated Ice Cream Company is recalling Special Order ice cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Special Order (Other) Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1286-2015·2015-03-04

    Elevated Tiramisu Ice Cream Recalled for Listeria Contamination Risk

    Elevated Ice Cream Company is recalling Tiramisu Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Tiramisu Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1356-2015·2015-03-04

    Lindt Chocolate Covered Raisins Recalled for Undeclared Hazelnuts

    Lindt & Sprungli USA is recalling specific lots of Milk Chocolate Covered Raisins because they may contain undeclared hazelnuts.

    Product
    Lindt Chocolate Specialties Milk Chocolate Covered Raisins,6.4 oz. packaged in a stand up bag (resealable pouch) Item Number: #8699 (or #8378)
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1274-2015·2015-03-04

    Elevated Pumpkin Ice Cream Recalled for Potential Listeria Contamination

    Elevated Ice Cream Company is recalling Pumpkin Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Pumpkin Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1138-2015·2015-03-04

    Invacare FDX Electric Wheelchairs Recalled for Fire Hazard

    Invacare is recalling 60 FDX, TDX, and Storm Series power wheelchairs because wire damage can cause smoking, sparking, or fire.

    Product
    FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1300-2015·2015-03-04

    Don Froylan Queso Oaxaca Cheese Recalled for Improper Pasteurization

    Ochoa's Queseria LLC is recalling Don Froylan brand Queso Oaxaca cheese because the milk was not pasteurized properly. The product was distributed in Oregon and Washington.

    Product
    Queso Oaxaca Whole Milk Mozarella Cheese, Don Froylan brand, packaged in 12 oz., 1 lb., and 5 lbs. 12 oz. package has UPC 8 85790 00010 8; 1 lb. package has UPC 8 85790 00009 2; 5 lbs. bulk package has no UPC.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1233-2015·2015-03-04

    Elevated Brandied Apricot Ice Cream Recalled for Listeria Risk

    Elevated Ice Cream Company is recalling Brandied Apricot Ice Cream due to potential Listeria monocytogenes contamination from recalled ice cream mix.

    Product
    Brandied Apricot Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1364-2015·2015-03-04

    Queseria Bendita Recalls Panela Soft Cheese Due to Listeria Risk

    Queseria Bendita is recalling Panela soft cheese due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Panela, Latin Style Soft Cheese, packaged in plastic wrap, Net Wt. 1 lb. The UPC is 6 10074 99341 4
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1235-2015·2015-03-04

    Elevated Cardamom Ice Cream Recalled for Listeria Risk

    Elevated Ice Cream Company is recalling Cardamom Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Cardamom Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1367-2015·2015-03-04

    Queseria Bendita Recalls Cotija Cheese Due to Listeria Risk

    Queseria Bendita is recalling 1 lb. packages of Cotija cheese in Oregon and Washington due to potential Listeria monocytogenes contamination.

    Product
    Cotija cheese is packaged in a plastic wrap, Net Wt. 1 lb. There is no UPC
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1248-2015·2015-03-04

    Elevated Dutch Malt Ice Cream Recalled for Listeria Risk

    Elevated Ice Cream Company is recalling Dutch Malt Ice Cream due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Dutch Malt Ice Cream Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1232-2015·2015-03-04

    Elevated Blueberry Italian Ice Recalled for Listeria Risk

    Elevated Ice Cream Company is recalling Blueberry Italian Ice due to potential Listeria monocytogenes contamination from a recalled ice cream mix.

    Product
    Blueberry Italian Ice. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1340-2015·2015-03-04

    Adams Extract & Spice Recalls Chili CN Seasoning for Undeclared Peanut

    Adams Extract & Spice LLC is recalling Chili CN Seasoning because it may contain undeclared peanut protein. Consumers should check for specific lot codes.

    Product
    Chili CN Seasoning 34.8125# Bag Item Code: J1302
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1359-2015·2015-03-04

    Gulf Coast Seasoned Flour Recalled for Possible Peanut Protein

    Gulf Coast Blenders is recalling Metairie Country Club Seasoned Flour because it contains ground cumin that may have peanut protein.

    Product
    GULF COAST BRAND METAIRIE COUNTRY CLUB SEASONED FLOUR, NET WEIGHT 50 lbs. (22.68 kg.), GULF COAST BLENDERS, INC., 7801 Townsend Place, New Orleans, LA 70126
    Category
    Food
    Distribution
    4 states
  • HighUSDA FSIS·039-2015·2015-03-04

    Bavarian Brand Loaf Recalled for Undeclared Soy Allergen

    Bavarian Meats is recalling approximately 1,400 pounds of Bavarian Brand Loaf products due to misbranding and an undeclared soy allergen.

    Product
    Bavarian Meat Products — Bavarian Meats Recalls Brand Loaf Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1322-2015·2015-03-04

    Adams Extract Menudo Seasoning Recalled for Undeclared Peanut

    Adams Extract & Spice LLC is recalling 50-pound bags of Menudo Seasoning because the product may contain undeclared peanut protein.

    Product
    50# Menudo Seasoning Item Code: 23024 Item UPCA: 041313230241
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1305-2015·2015-03-04

    Adams Menudo Seasoning Recalled for Undeclared Peanut Protein

    Adams Extract & Spice LLC is recalling specific lots of Menudo Seasoning because the product may contain undeclared peanut protein.

    Product
    Adams Pantry Basics Saver Size Menudo Seasoning Net Wt. 18 oz. (511 g) UPC: 041313023720; Flavor Ala Carte Menudo Seasoning (#32 FAC Menudo) 1.13 LB. Item Code: 02375 Item UPCA: 041313023751
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1071-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps With Failing Alarm Assemblies

    Hospira Inc. is recalling 315 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at all volume levels.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1073-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps with Silent Alarm Defect

    Hospira is recalling 4,656 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1074-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps With Silent Alarm Defect

    Hospira is recalling nine Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1176-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 22 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 18 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212, STERILE, Rx ONLY --- For single use only. ---Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1145-2015·2015-03-04

    Spacelabs Healthcare Recalls qube Compact Monitors for Boot Failure

    Spacelabs Healthcare is recalling 2,955 qube Compact Monitors because they may fail to boot up or reset to factory defaults after power on.

    Product
    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1136-2015·2015-03-04

    Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 16 Metasul Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1156-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 927 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns

    Navilyst Medical is recalling 454 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1186-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 33 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 60200057, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1348-2015·2015-03-04

    Frozen Shrimp Empanada Recalled for Undeclared Peanuts in Cumin

    Kabobs Inc is recalling Frozen Shrimp Empanadas because the cumin used contained undeclared peanuts. The product was distributed in Florida, Georgia, and Texas.

    Product
    Frozen Shrimp Empanada, 100 count, Ready to cook, Item #K718, Prepared by Kabob's Acquisition Inc., 5423 North Lake Drive, Lake City, Ga. 30260.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1163-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 5 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monito
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled for Potential Sterility Breach

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1190-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 61 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 15 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Potential Sterility Breach

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monito
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1349-2015·2015-03-04

    Frozen Vegetable Empanadas Recalled for Undeclared Peanuts

    Kabobs Inc is recalling frozen vegetable empanadas because the cumin used contains undeclared peanuts.

    Product
    Frozen Vegetable Empanada, 100 count, Ready to Cook, Item #K716, Prepared by Kabob's Acquisition Inc., 5423 North Lake Drive, Lake City, Ga. 30260.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1169-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 390 NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach.

    Product
    NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 255 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Left Heart Cath Kits Due to Sterility Concerns

    Navilyst Medical is recalling 62 units of NAMIC Left Heart Cath Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach.

    Product
    NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 32 units of NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitorin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled for Potential Sterility Breach

    Navilyst Medical is recalling 20 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1299-2015·2015-03-04

    Lime Chipotle Marinade Recalled Due to Peanut Protein Contamination

    Barhyte Specialty Foods Inc. is recalling Lime Chipotle Marinade due to peanut protein contamination. Consumers should stop using the product.

    Product
    Pacific Coast Selections Lime Chipotle Marinade, UPC 0 98487 10045 0; Saucy Mama Lime Chipotle Marinade, UPC 0 47281 40200 0; Product is packaged in clear, glass, 12 fluid ounce, ring neck bottle, with 38 mm black continuous thread closure covered with a black tamper evident
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1207-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 133 NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15E016000·2015-03-04

    Taizhou Tianda Seat Belts Recalled for Buckle Latching Defect

    Taizhou Tianda is recalling 480 seat belts manufactured in 2013 because improper buckle manufacturing may prevent easy unlatching, potentially hindering vehicle egress during emergencies.

    Product
    SEAT BELTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1354-2015·2015-03-04

    Thai Delight Burritos Recalled for Undeclared Soy and Sulfite

    The Lime Green Grocer, Inc. is recalling Thai Delight Burritos due to undeclared soy and sulfite allergens.

    Product
    Thai Delight Burrito, individually wrapped in clear plastic, keep refrigerated, serve hot or cold, Net wt. 11.5 oz (326g), UPC 7 94025 00190 5. The ingredients statement are listed "brown rice, peanut sauce (Peanuts, coconut milk, hot chili paste, turbinado, vegetable oil, gar
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1360-2015·2015-03-04

    Gulf Coast Seasoned Flour Recalled for Possible Peanut Contamination

    Gulf Coast Blenders is recalling Ralph Brennan's Seasoned Flour due to possible peanut protein contamination in the cumin ingredient.

    Product
    GULF COAST BRAND RALPH BRENNAN'S SEASONED FLOUR, NET WEIGHT 50 lbs. (22.68 kg.), GULF COAST BLENDERS, INC., 7801 Townsend Place, New Orleans, LA 70126
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1303-2015·2015-03-04

    Adams Pantry Basics Spices Recalled for Undeclared Peanut Protein

    Adams Extract & Spice LLC is recalling specific chili powder and ground cumin products because they may contain undeclared peanut protein.

    Product
    Adams Pantry Basics Chili Powder Net Wt. 2.82 oz (80 g) UPC: 041313017224; Adams Pantry Basics Value Size Chili Powder Net Wt. 7.48 oz (212 g) UPC: 041313017231; Adams Pantry Basics Saver Size Ground Cumin Net Wt. 16.8 oz (477 g) UPC: 041313023522
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0801-2015·2015-03-04

    Pacific Fusion Frozen Tuna Steak Recalled for High Histamine Levels

    Thai Ocean Venture Co., Ltd. is recalling Pacific Fusion Frozen Tuna Steak due to high histamine levels found in FDA samples.

    Product
    Pacific Fusion Frozen Tuna Steak Wild Caught Net Weight: 15 lb (240oz) 6.80 kg Ingredients: Tuna, tasteless smoke used as a preservative to promote color retention SKU: 0 75627 14610 3 Production Date: 10 MAR 2014 Best Before: 10 MAR 2016 Manufactured By: Thai Ocean Ventu
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1132-2015·2015-03-04

    Zimmer CoCr Femoral Heads Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 1,908 CoCr Femoral Heads due to potential sterile tray compromise. Undetected breaches could lead to contamination and periprosthetic infection.

    Product
    CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1155-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 489 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 7 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.

    Product
    NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 238 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled Due to Sterility Concerns

    Navilyst Medical is recalling 4 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only. Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled for Sterility Concerns

    Navilyst Medical is recalling 13 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 70 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2015·2015-03-04

    Zimmer Biolog Delta Ceramic Femoral Head Recall for Sterile Tray Compromise

    Zimmer GmbH is recalling 10,340 BIOLOX delta Ceramic Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection.

    Product
    Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1159-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Potential Sterility Breach

    Navilyst Medical is recalling 161 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 5 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitorin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 10 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 260 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2015·2015-03-04

    Hospira Plum A+ Infusion Pump Alarm Assembly Recall

    Hospira is recalling 3,939 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1196-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 5 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 60041632, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 3 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STERILE, Rx ONLY - For single use only. --- Device Listing Number D136588 NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 64 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 11 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 136 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 17 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 512 NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.

    Product
    NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monito
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2015·2015-03-04

    Brainlab Offset Cup Impactor Universal Recall Due to Sterilization Failure

    Brainlab AG is recalling 114 Offset Cup Impactor Universal units because their sterilization parameters are ineffective. The recall covers units distributed worldwide prior to January 13, 2015.

    Product
    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 69 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1146-2015·2015-03-04

    Biomet Spine Recalls Out-of-Specification 5.5 mm Rod Set Screws

    Biomet Spine is recalling 1,999 5.5 mm rod set screws because they are out of specification. The devices are used in spinal fixation constructs.

    Product
    Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to
    Category
    Medical Device
    Distribution
    Distributed nationwide

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