FDA-Device2014-09-24Class II
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson 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
Genesis BPS, LLC.
Hazard
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
Sold states
Nationwide Distribution & Switzerland
Affected count
7560 units
Manufactured in
65 Commerce Way, N/A, Hackensack, NJ, United States
Products
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2667-2014Don't want to check this manually?
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