Recall Z-2668-2014— Genesis BPS, LLC.
Class II · Terminated
Class II FDA medical device recall by Genesis BPS, LLC., initiated 2014-07-17, terminated 2016-03-04. It names one FDA 510(k) clearance: K050805. Product: 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: Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes..
- Recalling firm
- Genesis BPS, LLC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-17
- Terminated
- 2016-03-04
- Firm location
- Hackensack, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.