The Recall Desk

Archive

April 2018 recalls

622 recalls were announced in April 2018.

What the numbers show

Critical
19
Severe
135
High
332
Moderate
110
Low
26

Of the 622 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.

301–400 of 622

  • HighFDA (Devices)·Z-1367-2018·2018-04-18

    Teleflex Medical Recalls Latex Rebreathing Bags Due to Missing Allergen Warning

    Teleflex Medical Europe Ltd is recalling 107,962 latex rebreathing bags because they lack the required warning that the product contains natural rubber latex, which may cause allergic reactions.

    Product
    Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 21070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1010-2018·2018-04-18

    Precise Food Ingredients Recalls Roast Beef Gravy Seasoning for Salmonella Risk

    Precise Food Ingredients is recalling 896 pounds of Roast Beef Gravy Seasoning due to potential Salmonella contamination. The product was distributed in Texas.

    Product
    Roast Beef Gravy Seasoning Manufacturer's code: PF07040000 packaged in a multi-walled paper bag with poly liner, 28 pounds
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1141-2018·2018-04-18

    Poppies International Recalls Belgian Mini Eclairs Due to Listeria Risk

    Poppies International is recalling three brands of frozen Belgian mini eclairs because they may be contaminated with Listeria monocytogenes.

    Product
    GFS Belgian Mini Chocolate Topped Eclairs, Keep Frozen, Net Wt . 700 g.; Signature Select Belgian Style Mini Eclairs, Keep Frozen, 420 g; Delizza Patisserie Belgian Custard Cream Mini Eclairs, 420 g.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1007-2018·2018-04-18

    Taylor Shellfish Recalls Original Smoked Oysters Due to Packaging Error

    Taylor Shellfish Co is recalling Original Smoked Oysters in vacuum pouches because the packaging method is incorrect for this product type, posing a potential botulism risk if not kept cold.

    Product
    Original Smoked Oysters, packaged in vacuum pouches, net wt. 2.25 oz. or 16 oz.. UPC 47094 20002
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1320-2018·2018-04-18

    Mindray Hematology Diluent M-30D Recalled for Elevated Platelet Background Counts

    Mindray is recalling specific lots of M-30D diluent used with BC-3200 and BC-3600 analyzers because they may cause the system to produce an elevated platelet background count.

    Product
    Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for u
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1331-2018·2018-04-18

    Arrow International Recalls Certain Central Venous Catheterization Kits

    Arrow International is recalling specific lots of central venous and vessel catheterization kits because the seals may be incomplete, potentially compromising sterility.

    Product
    (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1335-2018·2018-04-18

    Arrow International Recalls Certain Lots of AGB+ Multi-Lumen CVC Kits

    Arrow International is recalling specific lots of AGB+ central venous catheter kits because the seals may be incomplete, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A,
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1333-2018·2018-04-18

    Arrow International Recalls Certain Lots of ARROWg+ard Blue CVC Kits

    Arrow International is recalling specific lots of ARROWg+ard Blue Central Venous Catheter (CVC) kits because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1336-2018·2018-04-18

    Arrow Hemodialysis Catheter Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of hemodialysis catheterization kits because they may not be completely sealed, potentially compromising sterility.

    Product
    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1371-2018·2018-04-18

    Hamilton-C2 Ventilator Units Recalled Due to Battery Fuel Gauge Inaccuracy

    Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.

    Product
    Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1373-2018·2018-04-18

    TriMed Inc. Recalls Hex Drivers Due to Epoxy Color Band Migration

    TriMed Inc. is recalling 1,525 hex drivers because the epoxy color band may migrate down the shaft or onto sterilization trays after sterilization.

    Product
    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1330-2018·2018-04-18

    Arrow International Recalls Arterial Catheterization Kits Due to Sterility Concerns

    Arrow International Inc is recalling specific lots of arterial catheterization kits because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1334-2018·2018-04-18

    Arrow International Recalls Arrowg+ard Blue PSI Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue PSI Kits because the catheters may not be completely sealed, preventing a guarantee of sterility.

    Product
    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1364-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may cause the driver to wedge or strip the screw.

    Product
    ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1354-2018·2018-04-18

    Bard Premature Infant Feeding Tube Recalled for Ineffective Fusion

    C.R. Bard is recalling 42,200 units of Bard Premature Infant Feeding Tubes due to potentially ineffective fusion between the tubing and the ENFit connector.

    Product
    Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tub
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2018·2018-04-18

    Lifeline HomeSafe AutoAlert Pendant Recall for Fall Detection Error

    Lifeline Systems is recalling Model FD100 HomeSafe AutoAlert Pendants because a programming error disables the fall detection feature.

    Product
    HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1011-2018·2018-04-18

    Bob's Red Mill Organic Amaranth Flour Recalled for Salmonella Risk

    Bob's Red Mill Natural Foods is recalling Organic Whole Grain Amaranth Flour due to potential Salmonella contamination. The product was distributed in ten US states, Mexico, and the UAE.

    Product
    Amaranth Flour, Organic Whole Grain, Item Number: 6001C224, Net wt. 22 oz. UPC 0 39978 00911 1. The label is read in parts: "***Bob's Red Mill ***ORGANIC WHOLE GRAIN AMARANTH FLOUR STONE GROUND*** NET WT 22 OZ ***keeps best refrigerated or frozen***".
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1357-2018·2018-04-18

    Bard Premature Infant Feeding Tubes Recalled for Ineffective Fusion

    C.R. Bard is recalling specific lots of Bard Premature Infant Feeding Tubes because the tubing and ENFit connector may not be effectively fused.

    Product
    Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tub
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1349-2018·2018-04-18

    Getinge Recalls VOLISTA StandOP Surgical Lights Due to Handle Detachment Risk

    Getinge is recalling 5,214 VOLISTA StandOP surgical lights because the central handle holder can detach, potentially dropping particles into the sterile field during procedures.

    Product
    VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2018·2018-04-18

    Zimmer GmbH Recalls Normed Charcot Osteotome Chisels for Disinfection Gap

    Zimmer GmbH is recalling Normed Charcot Osteotome Chisels because a gap between the handle and metal chisel may prevent proper disinfection or sterilization between uses.

    Product
    Normed Charcot Osteotome Chisel (Various sizes)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1372-2018·2018-04-18

    Hamilton-C3 Ventilator Battery Fuel Gauge Recall

    Hamilton Medical AG is recalling 739 Hamilton-C3 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.

    Product
    Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1323-2018·2018-04-18

    Arrow MAC Two-Lumen Central Venous Access Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of MAC Two-Lumen Central Venous Access Kits because the seals may be incomplete, preventing a guarantee of sterility.

    Product
    (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1329-2018·2018-04-18

    Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Po
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1355-2018·2018-04-18

    Bard Infant Feeding Tube Recalled for Ineffective Connector Fusion

    C.R. Bard is recalling 23,400 infant feeding tubes because the tubing and connector may not be effectively fused.

    Product
    Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Barcode Reading Failures

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may fail to read dilution barcodes, causing erroneous results that could delay treatment.

    Product
    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2018·2018-04-18

    Beckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors

    Beckman Coulter is recalling 288 AQUIOS CL Flow Cytometer Systems because the single tube loader may process the same sample with two different IDs, potentially causing erroneous results.

    Product
    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Under-Reporting Issue

    Beckman Coulter is recalling the iQ200 Series Urine Microscopy Analyzer because it may under-report casts when certain measurement settings are used. The issue could affect test results during initial setup or after settings are changed.

    Product
    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1325-2018·2018-04-18

    Arrow International Recalls Two-Lumen PICC Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of two-lumen PICC kits because the catheters may not be completely sealed, potentially compromising sterility.

    Product
    Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1332-2018·2018-04-18

    Arrow International Recalls Certain Lots of Cardiovascular Catheters for Sterility Concerns

    Arrow International Inc is recalling specific lots of cardiovascular catheters because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·18142·2018-04-18

    Primark Recalls Decorative Cushions Due to Fire Hazard

    Primark is recalling about 14,500 decorative cushions sold in the northeastern U.S. because they can catch fire if exposed to an ignition source.

    Product
    Decorative cushions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2018·2018-04-18

    Arrow PICC Kit Recall Due to Potential Sterility Seal Failure

    Arrow International is recalling specific lots of ARROW PICC Kits because the seals may not be completely closed, meaning the product's sterility cannot be guaranteed.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1326-2018·2018-04-18

    Arrow International Recalls Certain Lots of Central Venous Catheter Kits

    Arrow International is recalling specific lots of central venous catheter kits because they may not be completely sealed, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-4585
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1008-2018·2018-04-18

    All American Seasonings Recalls Lost Cajun Gumbo Base Due to Salmonella

    All American Seasonings is recalling Lost Cajun Gumbo Base because an ingredient was contaminated with Salmonella. The recall involves 23 bags distributed to one customer in Colorado.

    Product
    LOST CAJUN GUMBO BASE, T4014, PACK SIZE 45 lb bag, Blended by ALL AMERICAN SEASONINGS, 10600 E. 54th Ave., Units B & C, Denver, CO 80239
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·18V246000·2018-04-18

    Riverside Recalls 2015-2017 Motorhomes Due to Fire Extinguisher Defects

    Riverside RV is recalling 2015-2017 White Water, Water Fall, and Mt. McKinley motorhomes because certain fire extinguishers may clog or detach, posing injury risks.

    Product
    RIVERSIDE — RIVERSIDE WATER FALL, MT. MCKINLEY, WHITEWATER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V245000·2018-04-18

    Newmar Recalls Motorhomes Due to Headlight Beam Switching Defect

    Newmar is recalling specific 2013-2017 motorhomes because low beam headlights turn off when high beams are activated, reducing driver visibility.

    Product
    NEWMAR — NEWMAR LONDON AIRE, DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2018·2018-04-18

    Orthofix Recalls Connector System Set Screws Due to Size Discrepancies

    Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may prevent proper driver fit or cause stripping.

    Product
    ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1353-2018·2018-04-18

    Certified Safety Mfg Recalls First Aid Kits with Leaking Honeywell Eyewash

    Certified Safety Mfg Inc is recalling 748 first aid and emergency kits containing Honeywell eyewash due to leaking bottles. The affected units were distributed nationwide.

    Product
    First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye Wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1369-2018·2018-04-18

    Teleflex Recalls Simplastic Suprapubic Puncture Instruments for Missing Latex Warning

    Teleflex Medical Europe Ltd is recalling Simplastic Suprapubic Puncture Instruments because the packaging lacks a required warning that the products contain natural rubber latex.

    Product
    Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2018·2018-04-18

    ICU Medical Recalls Infusion Sets with Incorrect Spin Collars

    ICU Medical is recalling specific lots of sterile intravascular administration sets because they were manufactured with an incorrect spin collar.

    Product
    6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1321-2018·2018-04-18

    Mindray Hematology Diluent Recall for Elevated Platelet Background Counts

    Mindray is recalling specific lots of M-53D and M-30D hematology diluents because they may cause the analyzer to produce an elevated platelet background count.

    Product
    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1368-2018·2018-04-18

    Teleflex Medical Recalls Rectal Catheters Due to Missing Latex Warning

    Teleflex Medical Europe Ltd is recalling 6,340 rectal catheters because the packaging lacks a required warning that the product contains natural rubber latex.

    Product
    Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1109-2018·2018-04-18

    Diet Pepsi 6-Packs Recalled for Incorrect Aspartame-Free Labeling

    Pepsi Cola Bottling Company is recalling Diet Pepsi 6-packs because the outer packaging incorrectly states the product is 'Now Aspartame Free' when it actually contains aspartame.

    Product
    Diet Pepsi; NOW ASPARTAME FREE; 6 PACK; 16 OZ BOTTLES; 6-16 FLOZ BOTTLES (96 FL OZ)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2018·2018-04-18

    FDA Recalls Zhong Hua Jiu Menthol Patches for GMP Deviations

    United Pacific Co Ltd is recalling Zhong Hua Jiu (menthol 1%) Patches because they were produced with substandard GMP manufacturing processes.

    Product
    Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1345-2018·2018-04-18

    ICU Medical Recalls 7-inch Smallbore Infusion Sets with Incorrect Spin Collar

    ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots were distributed in the US, Canada, and Japan.

    Product
    7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1339-2018·2018-04-18

    Ethicon Recalls PDS Plus Sutures Due to Incorrect Expiry Date Labeling

    Ethicon, Inc. is recalling PDS Plus Antibacterial Sutures because three lots were labeled with a five-year expiry date instead of the correct two-year date.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0623-2018·2018-04-18

    Elroselabs Recalls Conzerol Hydrogen Peroxide Gel Due to cGMP Deviations

    Elroselabs Inc. is voluntarily recalling Conzerol Hydrogen Peroxide Gel 3% nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2018·2018-04-18

    ICU Medical Recalls Smallbore Extension Sets with Incorrect Spin Collars

    ICU Medical is recalling 11,500 smallbore extension sets manufactured with incorrect spin collars. The affected units were distributed in the US, Canada, and Japan.

    Product
    6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, steril
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1370-2018·2018-04-18

    Teleflex Baker Jejunostomy Tubes Recalled for Missing Latex Warning

    Teleflex Medical Europe Ltd is recalling 200 Baker Jejunostomy Tubes because the packaging lacks a required warning that the product contains natural rubber latex.

    Product
    Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0621-2018·2018-04-18

    Elroselabs Recalls Conzerol Topical Cream Due to Manufacturing Deviations

    Elroselabs Inc. is voluntarily recalling Conzerol topical cream nationwide due to cGMP deviations. The recall was initiated in March 2018 and terminated in December 2020.

    Product
    Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1347-2018·2018-04-18

    ICU Medical Recalls Infusion Sets with Incorrect Spin Collars

    ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.

    Product
    14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0622-2018·2018-04-18

    Elroselabs Recalls Molleave OTC Product Due to cGMP Deviations

    Elroselabs Inc. is voluntarily recalling Molleave, 2 oz bottles, due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.

    Product
    Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1006-2018·2018-04-18

    Taylor Shellfish Recalls Smoked Scallops for Low Salt Content

    Taylor Shellfish Co is recalling smoked scalps in Oregon and Washington because the product did not meet minimum salt requirements.

    Product
    Smoked Scallops, packaged and frozen in vacuum pouches, 4 oz & 16 oz packages. The 4 oz package has UPC 47094 20026
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1317-2018·2018-04-18

    Smith & Nephew Recalls D-RAD Self-Tapping Locking Screws

    Smith & Nephew is recalling D-RAD Self-Tapping Locking Screws because they were machined out of specification. The screws measured over tolerance within the head thread form.

    Product
    D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0698-2018·2018-04-18

    InvaGen Recalls Decitabine for Injection Due to Impurity Failures

    InvaGen Pharmaceuticals is recalling Decitabine for Injection because the product failed water content and impurity specifications.

    Product
    Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1346-2018·2018-04-18

    ICU Medical Recalls Smallbore Extension Sets Due to Incorrect Spin Collar

    ICU Medical is recalling 100 pouches of 5-inch Smallbore Extension Sets because they were manufactured with an incorrect spin collar.

    Product
    5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic devic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1338-2018·2018-04-18

    Ethicon Recalls PDS Plus Antibacterial Sutures Due to Incorrect Expiry Dates

    Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they were labeled with an incorrect expiry date of five years instead of two.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1340-2018·2018-04-18

    Ethicon Recalls PDS Plus Antibacterial Sutures Due to Incorrect Expiry Dates

    Ethicon is recalling PDS Plus Antibacterial Sutures because three lots were labeled with an incorrect five-year expiry date instead of the correct two-year date.

    Product
    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1352-2018·2018-04-18

    Magstim Rapid Therapy System Recalled for Missing User Manuals

    The Magstim Company Limited is recalling 43 Magstim Rapid Therapy Systems because user manuals were not supplied with the devices.

    Product
    Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvemen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1013-2018·2018-04-18

    Bestco Signature Care Calcium Chews Recalled for Vitamin D Labeling Error

    Bestco, Inc. is recalling Signature Care Calcium Chews because the packaging declares 25 mcg of Vitamin D, but the product actually contains 12.5 mcg.

    Product
    Signature Care Calcium Chews; Dietary Supplement; 500 mg Calcium; 25 mcg Vitamin D; Chocolate; 100 chews; Serving Size 1 chew;
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1359-2018·2018-04-18

    Aesculap Strauss Penis Clamp Recalled Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Strauss Penis Clamps because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Strauss Penis Clamp 130MM/General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0626-2018·2018-04-18

    FDA Recalls Tramadol Hydrochloride Tablets Due to Labeling Errors

    Lake Erie Medical & Surgical Supply Inc. is recalling 16 cartons of Tramadol Hydrochloride 50 mg tablets due to incorrect or missing lot and expiration dates.

    Product
    Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Devices)·Z-1358-2018·2018-04-18

    Aesculap Recalls Doyen-Collin Mouth Gags Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Doyen-Collin Mouth Gags because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Doyen-Collin Mouth Gag 120MM/ General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1322-2018·2018-04-18

    Clinical Diagnostic Systems Recalls VITROS TSH Reagent Packs Due to Calibration Issues

    Clinical Diagnostic Systems is recalling specific lots of VITROS TSH Reagent Packs because they may generate higher-than-expected calibrator signals, potentially causing calibration curves to fall outside quality parameters.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1350-2018·2018-04-18

    Neuropro Spinal Jaxx Interbody Fusion Device Recall for Incorrect Size Etching

    Neuropro Spinal Jaxx is recalling six Spinal Jaxx Interbody Fusion Devices because the implant size is incorrectly etched on the device, although the box label is correct.

    Product
    Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·18140·2018-04-17

    Schneider Electric Recalls Square D Safety Switches Due to Electrical Shock Hazard

    Schneider Electric is recalling Square D safety switches because power may remain on when the handle is in the OFF position, posing an electrical shock hazard.

    Product
    Square D brand General Duty 30 & 60A, 120/240-volt, 2-phase and 3-phase NEMA 3R Safety Switches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V241000·2018-04-17

    KZRV Recalls 2019 Connect Trailers Due to Incorrect Circuit Breaker

    KZRV is recalling 2019 Connect recreational trailers because an incorrect circuit breaker may increase the risk of a fire. Dealers will replace the part free of charge.

    Product
    KZRV — KZRV CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V242000·2018-04-17

    KZRV Recalls 2018-2019 Trailers Due to Awning Deployment Risk

    KZRV is recalling 2018-2019 recreational trailers because the awning may deploy while moving, increasing the risk of a crash.

    Product
    KZRV — KZRV SIDEWINDER, SPORTSMEN, VENOM, CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V243000·2018-04-17

    Gulf Stream Motorhomes Recalled for Missing Side Marker Lights

    Gulf Stream is recalling 2016-2018 Conquest and B Touring Cruiser motorhomes because they lack required intermediate side marker lights, increasing crash risk.

    Product
    GULF STREAM — GULF STREAM CONQUEST, B TOURING CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V240000·2018-04-16

    Nissan Recalls Titan and Titan XD Trucks for Missing Load Labels

    Nissan is recalling 2016-2018 Titan and Titan XD trucks because missing labels may allow owners to overload the vehicles, increasing crash risk.

    Product
    NISSAN — NISSAN TITAN XD, TITAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·033-2018·2018-04-14

    Fresh Foods Manufacturing Recalls Ready-to-Eat Salads Due to E. coli O157:H7

    Fresh Foods Manufacturing Co. is voluntarily recalling approximately 8,757 pounds of ready-to-eat salad products due to possible E. coli O157:H7 contamination.

    Product
    Fresh Food Manufacturing Company — Fresh Foods Manufacturing Co. Recalls Ready-To-Eat Salad Products Due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·18V237000·2018-04-13

    KME Predator Fire Trucks Recalled for Hydraulic Hose Fire Risk

    KME is recalling 38 Predator fire trucks because improperly routed hydraulic hoses may contact electrical components, creating a fire risk.

    Product
    KME — KME PREDATOR SS PUMPER, PREDATOR AERIAL, PREDATOR PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V236000·2018-04-13

    Newmar Recalls 2018 Motorhomes Due to Electrical Connection Fire Risk

    Newmar is recalling 2018 motorhomes because loose electrical connections in the breaker box may overheat and increase the risk of a fire.

    Product
    NEWMAR — NEWMAR VENTANA, BAY STAR, LONDON AIRE, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V235000·2018-04-13

    Isuzu Recalls NPR Models Due to Brake Switch Retainer Defect

    Isuzu is recalling 2018-2019 NPR models because a brake switch retainer may not be secured, potentially disabling acceleration and increasing crash risk.

    Product
    ISUZU — ISUZU NPR XD, NPR HD, NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V231000·2018-04-12

    2018 Jeep Wrangler Recall for Rear Underbody Ladder Rail Corrosion

    Chrysler is recalling 2018 Jeep Wrangler vehicles because the rear underbody ladder rail may corrode, potentially weakening the floor pan and loosening the rear seat mount.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18736·2018-04-12

    L.L.Bean Recalls Allagash Hunting Knife Due to Laceration Hazard

    L.L.Bean is recalling Allagash fixed blade hunting knives because the blade can cut through the leather sheath, posing a laceration hazard.

    Product
    Allagash fixed blade hunting knife with sheath
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V230000·2018-04-12

    GM Recalls 2018 Buick Regal for Rear Seat Belt Routing Defect

    General Motors is recalling 2018 Buick Regal vehicles because rear seat belts may be improperly routed, potentially failing to restrain passengers in a crash.

    Product
    BUICK — BUICK REGAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V234000·2018-04-12

    Forest River Recalls 2018-2019 FR3 and Georgetown RVs for Door Latch Defect

    Forest River is recalling 2018-2019 FR3 and Georgetown recreational vehicles because the entry door latch may not engage fully, allowing the door to open unexpectedly while moving.

    Product
    FOREST RIVER — FOREST RIVER FR3, GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0991-2018·2018-04-11

    King Arthur Coconut Flour Recalled Due to Salmonella Contamination

    The King Arthur Flour Company is recalling 100% Organic Finely Ground Coconut Flour because it tested positive for Salmonella. Consumers should stop using the product.

    Product
    King Arthur Flour, 100% Organic, Finely Ground, Coconut Flour, UPC 0 71012 10702 5, Distributed by: The King Arthur Flour Co., Inc., Norwich, Vermont 05055 Product of the Philippines and/or Sri Lanka.
    Category
    Food
    Distribution
    26 states
  • CriticalFDA (Food)·F-0990-2018·2018-04-11

    Healthy Nut Factory Organic Coconut Smiles Recalled for Salmonella Contamination

    Health Nuts is recalling Healthy Nut Factory Organic Coconut Smiles due to potential Salmonella contamination. Consumers in New York should stop eating the product.

    Product
    Healthy Nut Factory ORGANIC COCONUT SMILES, Net Wt. 7 oz, UPC: 8 13449 02099 3
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0993-2018·2018-04-11

    Natural Grocers Organic Coconut Smiles Recalled for Salmonella

    Natural Grocers by Vitamin Cottage is recalling Organic Coconut Smiles because the product tested positive for Salmonella.

    Product
    Natural Grocers Organic Coconut Smiles, 10 oz. plastic resealable bag, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1004-2018·2018-04-11

    Wegmans Yogurt Raisins Recalled for Undeclared Peanuts

    First Source, LLC is recalling Wegmans Yogurt Raisins due to undeclared peanuts. The product was sold in six states.

    Product
    Wegmans Yogurt Raisins, 9 OZ (255g), in a plastic tub, UPC: 0 77890 31832 4,
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0989-2018·2018-04-11

    International Harvest Organic Dried Coconut Recalled for Salmonella

    International Harvest, Inc. is recalling Organic Go Smile! Dried Coconut Raw because the product tested positive for Salmonella.

    Product
    Coconut Smiles - Retail: International Harvest Brand Organic Go Smile! Dried Coconut Raw, in a 9 oz. poly/plastic bag, UPC: 7 39446 40220 7 NON GMO; Bulk: 25 lb. boxes
    Category
    Food
    Distribution
    24 states
  • SevereUSDA FSIS·031-2018·2018-04-11

    Conagra Recalls Salisbury Steak Products Due to Bone Contamination

    Conagra Brands is recalling approximately 135,159 pounds of Salisbury steak products due to possible bone contamination. The recall follows reports of minor oral injuries.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — Conagra Brands Inc. Recalls Salisbury Steak Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V229000·2018-04-11

    Audi Recalls 2012-2017 Models Due to Coolant Pump Fire Risk

    Volkswagen Group of America is recalling specific Audi models because a coolant pump defect may cause overheating or short-circuiting, increasing the risk of a fire.

    Product
    AUDI — AUDI A6, A5, Q5, A4 ALLROAD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2018·2018-04-11

    GE Healthcare Recalls Monica IF24 Interface System Due to Signal Swap Risk

    GE Healthcare is recalling 355 Monica IF24 Interface Systems because incorrectly reconnected cables can cause fetal and maternal heart rate signals to be displayed incorrectly.

    Product
    Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0994-2018·2018-04-11

    Frank & Tony's Red Onion Sauce Recalled for Undeclared Fish

    Kaltic Food Packaging is recalling Frank & Tony's New York Style Red Onion Sauce because it contains undeclared fish (anchovy).

    Product
    FRANK & TONY'S NEW YORK STYLE RED ONION SAUCE, 15oz. (420g) glass jar, UPC: 6 00231 21502 2
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1295-2018·2018-04-11

    Magellan LeadCare II Blood Lead Analyzer Recalled for Battery Overheating Risk

    Magellan Diagnostics is recalling LeadCare II Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.

    Product
    LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1300-2018·2018-04-11

    DePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots

    DePuy Spine is recalling specific lots of the Confidence Plus Kit Spinal Cement System because they may contain incorrect amounts of contrast medium, making the product difficult or impossible to visualize on x-ray.

    Product
    Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for f
    Category
    Medical Device
    Distribution
    0 states

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