Z-2667-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- July 17, 2014
- Termination Date
- March 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7560 units
Product Description
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
Reason for Recall
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Distribution Pattern
Nationwide Distribution & Switzerland
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