FDA Medical Device Recalls (openFDA)
Genesis BPS, LLC.: 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 number
- Z-2669-2014
- Recalling firm
- Genesis BPS, LLC.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-07-17
- Posted
- 2014-09-18
- Terminated
- 2016-03-04
- 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-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.
- Quantity
- 4608 units
- Distribution
- Nationwide Distribution & Switzerland
- Lot, serial or model codes
- Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301
- 510(k) numbers
- ["K050805"]
- PMA numbers
- not on file
- Product code
- BRZ
- Firm FEI
- 1000527169
- Firm city
- Hackensack
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28