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
Z-2667-2014
Product summary
- Event
- Event 68874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7560 units
- Official record key
device-enforcement:Z-2667-2014
Official wording
Reason: Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Code information: Cat #405-530BD Lot #3640-23476; 3640-23506; 3640-24153; 3640-24206; 3640-24398; 3640-24485; 3640-24517; 3640-23969; 3640-24330; 3640-24521
Distribution pattern: Nationwide Distribution & Switzerland
Derived failure modes
-
Unknown
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.