Genesis BPS, LLC.: Medical Device Recall in 2014 - (Recall #: Z-2668-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 17, 2014

Date Posted: September 24, 2014

Recall Number: Z-2668-2014

Event ID: 68874

Reason for Recall:

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

Status: Terminated

Product Quantity: 7272 units

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

Distribution Pattern:

Nationwide Distribution & Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated