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    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    FDA Recall
    Terminated ·Dukal Corp.·Product code FPY·June 1, 2017

    API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.

    FDA Recall
    Terminated ·Biomerieux France Chemin De L'Or Chemin De L'Orme Marcy L'Etoile France·November 8, 2013

    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.

    FDA Recall
    Terminated ·Biomerieux France Chemin De L'Or Chemin De L'Orme Marcy L'Etoile France·November 8, 2013

    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Recall
    Terminated ·Biomerieux France Chemin De L'Or Chemin De L'Orme Marcy L'Etoile France·November 8, 2013

    API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LIB·March 6, 2014

    API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LIB·March 6, 2014

    API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LIB·January 8, 2016

    FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LIB·March 6, 2014

    ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LIB·March 6, 2014

    Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·March 20, 2008

    Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·March 20, 2008

    API 50 CH, Model 50300

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JSC·September 30, 2021

    Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·March 20, 2008

    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.

    FDA Recall
    Terminated ·Ab Sciex·Product code DOP·July 15, 2014

    API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code JXB·December 20, 2021

    VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0204-01 Otological Ventilation Tubes, Catalog Number VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0406-01 Otological Ventilation Tubes, Catalog Number VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-01 Otological Ventilation Tubes, Catalog Number VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0503-50 Otological Ventilation Tubes, Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-0507-01 Otological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT0508-50 Otological Ventilation Tubes, Catalog Number VT-0508-50, Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1002-50 Otological Ventilation Tubes, Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1035-01 Otological Ventilation Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT1204-01 Otological Ventilation Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. VT-1421-01 Otological Ventilation Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. ET-ABGDT-45 Distributed By API Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-GTST-45-12, Distributed By API Anthony products, Inc., ET-GTST-45-12, T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-SPDT-40T, Distributed By API Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. ET-TBDT-45 Distributed By API Anthony products, Inc., ET-TBDT-45 Reuter Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.

    FDA Recall
    Terminated ·Micromedics, Inc.·Product code ETD·March 15, 2010

    Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-333-33, catalog # MIH-3333: 3 mL fill in 12 mL syringe; b) NDC# 64253-333-35, catalog # MIH-3335: 5 mL fill in 12 mL syringe

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·November 1, 2010

    Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·November 1, 2010

    Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-222-21, catalog # MIH-2221: 1 mL fill in 6 mL syringe; b) NDC# 64253-222-23, catalog # MIH-2223: 3 mL fill in 6 mL syringe; c) NDC# 64253-222-35, catalog # MIH-2235: 5 mL fill in 12 mL syringe

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·November 1, 2010

    Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs

    FDA Recall
    Terminated ·Church & Dwight Inc·June 11, 2013