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
This recall has been terminated (originally issued September 18, 2014).
- Company
- Genesis Bps, Llc.
- Recall Initiated
- July 17, 2014
- Posted
- September 18, 2014
- Terminated
- March 4, 2016
- Recall Number
- Z-2668-2014
- Quantity
- 7272 units
- Firm Location
- Hackensack, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Distribution
Nationwide Distribution & Switzerland
Lot / Code Info
Cat #405-560BD Lot # 3650-23508; 3650-24116; 3650-24332; 3650-24399; 3650-24487; 3650-24519; 3650-23478; 3650-23971 Cat # 405-560MJ Lot #3630-23509; 3630-23972; 3630-24181; 3630-24333; 3630-24397; 3630-24488; 3630-24152
Root Cause
No Marketing Application
Action Taken
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 (info@genesisbps.com). 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.