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Genesis BPS, LLC. recalls Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and delive
Recalled September 24, 2014 · FDA recall Z-2669-2014 · Genesis BPS
Hazard
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes. · FDA Class II
Units
4608 units
Sold at
Nationwide Distribution & Switzerland
Description
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
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.
Manufacturer(s)
Genesis BPS, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →