Recall Z-2668-2014 ยท BRZ Set, Blood Transfusion
Genesis BPS, LLC.
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
| Date | Sep 18, 2014 (initiated Jul 17, 2014) |
| Status | Terminated |
| Reason | Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. |
| Root cause | No Marketing Application |
| Action | Genesis BPS sent an Urgent Medical Device Recall letter with a Recall Letter/Confirmation Form on July 17, 2014 to all affected customers. Customers were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if there is further distribution of the product, customers should be identified and be notified of the recall. Product use should be discontinued and disposed of according to applicable federal regulations and internal protocols. The attached confirmation form should be completed and returned to Genesis by either fax or (201) 708-1104 or e-ma |
| Quantity | 7272 units |
| Distribution | Nationwide Distribution & Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050805 | 30 ML OR 60 ML PEDI-SYRINGE FILTER Blood Products Specialties, LLC, Jun 20, 2005 |