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.
Recall
- Recall Number
- Z-2669-2014
- Event Number
- 68874
- Firm
- Genesis BPS, LLC.
- FEI Number
- 1000527169
- Product Code
- BRZ
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- July 17, 2014
- Posted
- September 18, 2014
- Terminated
- March 4, 2016
- Address
- 65 Commerce Way, Hackensack, NJ, 07601-6302
Description
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.
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
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-mail ([email protected]). Questions can be directed to (201) 708-1400 ext 2004 (9:00 and to 5:00 pm EST). For questions regarding this recall call 201-488-1174.
Nationwide Distribution & Switzerland
4608 units