Recall Z-2669-2014— Genesis BPS, LLC.

Name: FDA recall Z-2669-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-17

Class II · Terminated

Class II FDA medical device recall by Genesis BPS, LLC., initiated 2014-07-17, terminated 2016-03-04. It names one FDA 510(k) clearance: K050805. 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.. Reason: Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes..

Recalling firm: Genesis BPS, LLC.
Classification: Class II
Status: Terminated
Initiated: 2014-07-17
Terminated: 2016-03-04
Firm location: Hackensack, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K050805 — 30 ML OR 60 ML PEDI-SYRINGE FILTERBlood Products Specialties, LLC·cleared 2005-06-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

Reason for recall

Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.