Home / Recalls / Genesis BPS, LLC. / Z-2668-2014

Z-2668-2014 Class II Terminated

Recalled by Genesis BPS, LLC. — Hackensack, NJ

Recall Details

Product Type: Devices
Report Date: September 24, 2014
Initiation Date: July 17, 2014
Termination Date: March 4, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7272 units

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide Distribution & Switzerland

Code Information

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