The Recall Desk

Archive

March 2015 recalls

559 recalls were announced in March 2015.

What the numbers show

Critical
101
Severe
171
High
223
Moderate
50
Low
14

Of the 559 recalls this month scored against our rubric, 18% are Critical, 31% are Severe.

401–500 of 559

  • SevereFDA (Food)·F-1291-2015·2015-03-04

    Elevated Vanilla Bean Ice Cream Recalled for Listeria Contamination Risk

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

    Product
    Vanilla Bean 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-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 (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-1237-2015·2015-03-04

    Elevated Chocolate Almond Ice Cream Recalled for Listeria Risk

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

    Product
    Chocolate Almond 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-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-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-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-1368-2015·2015-03-04

    Queseria Bendita Recalls Sour Cream for Potential Listeria Contamination

    Queseria Bendita is recalling 1 lb. plastic tubs of Sour Cream/Crema Agria due to a potential for Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Sour Cream/Crema Agria is packaged in a plastic tub, Net Wt. 1 lb. The UPC is 0 94922 10608 7.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1251-2015·2015-03-04

    Elevated Ginger Ice Cream Recalled for Listeria Contamination Risk

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

    Product
    Ginger 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-1318-2015·2015-03-04

    Jardines Chili Pouch Recalled for Undeclared Peanut Protein

    Adams Extract & Spice LLC is recalling Jardines Chili Pouch B due to the potential presence of undeclared peanut protein.

    Product
    Jardines Chili Pouch B Item Code: 16935 (Quantity: 200 EA. 0.18 LB)
    Category
    Food
    Distribution
    23 states
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Food)·F-1225-2015·2015-03-04

    Fresh Foods Manufacturing Recalls Firecracker Burger Kits Due to Cumin Recall

    Fresh Foods Manufacturing Co. is recalling Firecracker Burger Kits because they contain cumin currently being recalled by the supplier.

    Product
    Cardboard box contain 6 paper packets each labeled as: Fresh Food Manufacturing Company Firecracker Burger Kit Keep Refrigerated Mix By: 5/25/2015
    Category
    Food
    Distribution
    0 states
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    50 states
  • 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-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 (Food)·F-1307-2015·2015-03-04

    Adams Brisket Rub Recalled for Undeclared Peanut Protein

    Adams Extract & Spice LLC is recalling specific sizes of Adams Brisket Rub because the product may contain undeclared peanut protein.

    Product
    Adams Brisket Rub Net Wt. 13.47 oz (382 g) UPC: 041313024338; Adams Brisket Rub Net Wt. 32 oz. (908 g) UPC: 041313024345
    Category
    Food
    Distribution
    23 states
  • SevereFDA (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
  • 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-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-1280-2015·2015-03-04

    Elevated Root Beer Float Ice Cream Recalled for Listeria Risk

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

    Product
    Root Beer Float 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-1249-2015·2015-03-04

    Elevated Ice Cream Recalled for Potential Listeria Contamination

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

    Product
    Eggnog 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-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-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-1284-2015·2015-03-04

    Elevated Sweet Cream Ice Cream Recalled for Listeria Risk

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

    Product
    Sweet Cream 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-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…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Food)·F-1252-2015·2015-03-04

    Elevated Ginger Snap Ice Cream Recalled for Listeria Contamination Risk

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

    Product
    Ginger Snap 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-1282-2015·2015-03-04

    Elevated Strawberry Ice Cream Recalled for Potential Listeria Contamination

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

    Product
    Strawberry 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-1308-2015·2015-03-04

    Adams Pantry Basics Multi-Season Seasoned Salt Recalled for Undeclared Peanut

    Adams Extract & Spice LLC is recalling specific lots of Multi-Season Seasoned Salt because the product may contain undeclared peanut protein.

    Product
    Adams Pantry Basics Multi-Season Seasoned Salt Net Wt. 30 oz (851 g) UPC: 041313024888; 50# Multi Seasoning Item Code: 06095 Item UPCA: 041313060954; 25# Multi Seasoning Item Code: 06096 Item UPCA: 041313060961
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1259-2015·2015-03-04

    Elevated Licorice Ice Cream Recalled for Listeria Contamination Risk

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

    Product
    Licorice 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-1275-2015·2015-03-04

    Elevated Ice Cream Recalls Raspberry Italian Ice Due to Listeria Risk

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

    Product
    Raspberry 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
  • SevereNHTSA·15V127000·2015-03-04

    Freightliner Recalls 2007-2011 Cascadia Trucks for Electrical Fire Risk

    Daimler Trucks North America is recalling 2007-2011 Freightliner Cascadia trucks because water leaks may cause electrical shorts, leading to trailer light failures or fires.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0393-2015·2015-03-04

    Par Pharmaceutical Recalls Mafenide Acetate Topical Solution Due to Foreign Substances

    Par Pharmaceutical Inc. is recalling Mafenide Acetate 5% Topical Solution packets due to the presence of oxidized steel, organic material, and shredded polypropylene.

    Product
    Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    50 states
  • SevereNHTSA·15V129000·2015-03-04

    NABI Recalls 2014 40LFW Buses Due to Improperly Torqued Tie Rod Nuts

    NABI is recalling 63 model year 2014 40LFW city transit buses because improperly torqued tie rod nuts may cause loss of vehicle control and increase crash risk.

    Product
    NABI — NABI 40LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1304-2015·2015-03-04

    Adams Ground Cumin Recalled for Undeclared Peanut Protein

    Adams Extract & Spice LLC is recalling specific sizes of Ground Cumin because the product may contain undeclared peanut protein.

    Product
    Adams Pantry Basics Ground Cumin Net Wt. 2.82 oz (80 g) UPC: 041313019525; Adams Pantry Basics Value Size Ground Cumin Net Wt. 6.70 oz (190 g) UPC: 041313019532; Adams Pantry Basics Saver Size Ground Cumin Net Wt. 16 oz (454 g) UPC: 041313023126; No brand name Cumin, Ground 50#…
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1180-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Sterility Verification Issues

    Navilyst Medical is recalling 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, UPN H749601801561, REF/Catalog No. 60180156, 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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 541 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 H965607011741, REF/Catalog No. 60701174, 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-1183-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 180 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a risk of sterility breach and infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043, 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
  • 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 (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-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-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-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-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 (Food)·F-1353-2015·2015-03-04

    VeggieLand Recalls Chili-Bean Veggiburgers Due to Undeclared Peanut Protein

    J P Veggies Inc. DBA VeggieLand is recalling Chili-Bean Fresh Veggiburgers because they may contain undeclared peanut protein from ground cumin.

    Product
    Chili-Bean Fresh Veggiburger, 4 Pre-Grilled Patties, All Natural Meatless Patties, Net Wt. 10 oz. (284)g)
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1165-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 105 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, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, 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-1168-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recall Due to Sterility Concerns

    Navilyst Medical is recalling 5 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 H749601113111, REF/Catalog No. 60111311, 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-1135-2105·2015-03-04

    Zimmer CoCr Femoral Heads Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 6,109 CoCr femoral heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease
    Category
    Medical Device
    Distribution
    45 states
  • 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…
    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…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1133-2015·2015-03-04

    Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 30 Metasul Femoral Head units due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    Metasul 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
  • HighCPSC·15722·2015-03-04

    Melville Direct Recalls Aquarium Motion Lamps Due to Fire Hazard

    Melville Direct is recalling about 3,600 Aquarium Motion Lamps sold by Bits & Pieces because they can overheat and spark, posing a fire hazard.

    Product
    Aquarium Motion Lamp
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1362-2015·2015-03-04

    Rex King of Spice Cajun Creole Seasoning Recalled for Peanut Allergen

    Gulf Coast Blenders is recalling Rex King of Spice Cajun Creole Seasoning because the cumin used may contain peanut protein.

    Product
    REX KING OF SPICE (R) CAJUN CREOLE SEASONING, NET WEIGHT 4.62 oz. (131 g), Produced Exclusively for: REX FINE FOODS, New Orleans, LA 70126
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1171-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 124 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 H7496013148131, REF/Catalog No. 601314813, 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-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-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-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-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 (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-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 (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
  • 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-1350-2015·2015-03-04

    Frozen Corn and Black Bean Tart Recalled for Undeclared Peanuts

    Kabobs Inc is recalling frozen Yucatan Style Roasted Corn & Black Bean Tarts because the cumin used contains undeclared peanuts.

    Product
    Frozen Yucatan Style Roasted Corn & Black Bean Tart, Item #K4072, Prepared by Kabob's Acquisition Inc., 5423 North Lake Drive, Lake City, Ga. 30260.
    Category
    Food
    Distribution
    3 states
  • 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-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
  • HighCPSC·15090·2015-03-04

    Dirt Devil Hand Vac Turbo Tool Recalled for Laceration Hazard

    CPSC recalls Dirt Devil Scorpion Turbo Tool accessories because the internal fan can break and eject, posing a laceration risk to users.

    Product
    Dirt Devil® Scorpion® Turbo Quick Flip Hand Vac Turbo Tool Accessory
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 19 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, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, 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-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-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-1164-2015·2015-03-04

    Navilyst NAMIC Convenience Kit Recalled Due to Sterility Concerns

    Navilyst Medical is recalling 602 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, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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
  • HighFDA (Devices)·Z-1157-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 16 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, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1185-2015·2015-03-04

    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 shelf life testing, posing a risk of sterility breach and infection.

    Product
    NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, 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…
    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-1206-2015·2015-03-04

    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 H965PK193168S1, REF/Catalog No. PK193168S, 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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