January 17, 2024Medical DevicesFDA
Cordis US Corp recalls MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Hazard: Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
January 17, 2024Medical DevicesFDA
Cordis US Corp recalls MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Hazard: Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
January 17, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Applic
Hazard: The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
January 17, 2024Medical DevicesFDA
Townsend Design recalls SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Hazard: Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
January 17, 2024Medical DevicesFDA
Townsend Design recalls SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 1
Hazard: Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
January 17, 2024Medical DevicesFDA
Townsend Design recalls CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C
Hazard: Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM G
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, T
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CM
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c)
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12M
Hazard: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of th
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for i
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
January 17, 2024Medical DevicesFDA
Abiomed, Inc. recalls Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body
Hazard: Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis