Z-2669-2014Class II

Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare...

Name: Z-2669-2014 Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare...
Creator: Genesis BPS, LLC.
Published: 2014-07-17
License: https://open.fda.gov/license/

Genesisbps LLC / initiated 2014-07-17 / Terminated

FDA source

Genesis BPS, LLC. began a recall of 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... on 2014-07-17. FDA classified it as Class II and gives the reason as "Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2669-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-17
Posted: 2014-09-18
Terminated: 2016-03-04
Recalling firm: Genesisbps 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.
Product code: BRZ Set, Blood Transfusion
Reason for recall: Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
FDA 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 ([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.
Quantity in commerce: 4608 units
Distribution: Nationwide Distribution & Switzerland
Product codes and lots: Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2669-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2667-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-18
Z-2668-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-18
Z-2669-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-18

Product code BRZ

K050805Class II30 Ml or 60 Ml Pedi-Syringe FilterBlood Products Specialties, LLC / cleared 2005-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)