The Recall Desk

FDA (Devices) recall action 68874

Genesis BPS, LLC. recalled 3 products on 2014-09-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-09-24
Critical
0
Units
19,440

Why these products were recalled

Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2014-09-24

    Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance

    Genesis BPS, LLC. is recalling 7,272 units of Pedi-Pak Pedi-Syringe Filter 60 mL syringes because the company failed to notify the FDA of material changes.

    Product
    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-09-24

    Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance

    Genesis BPS, LLC is recalling 4,608 units of Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringes because the company failed to notify the FDA of material changes.

    Product
    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-09-24

    Genesis BPS Recalls Pedi-Pak Syringe Filters for Unreported Changes

    Genesis BPS is recalling 7,560 units of Pedi-Pak Pedi-Syringe Filters because the company failed to notify the FDA of material changes to the device.

    Product
    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Distribution
    0 states