Home / Recalls / Genesis BPS, LLC. / Z-2669-2014

Z-2669-2014 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
4608 units

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.

Distribution Pattern

Nationwide Distribution & Switzerland

Code Information

Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301

Other recalls by Genesis BPS, LLC.

  • Z-2668-2014 Class II — Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Ge (July 17, 2014)
  • Z-2667-2014 Class II — Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS (July 17, 2014)