FDAFDA · Food and drugs·Recall number Z-2669-2014
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.
Published September 24, 2014 · Recall initiated: July 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Genesis BPS, LLC.
- Distributor
- Nationwide Distribution & Switzerland
- Lot
- Cat #405-535MJ Lot # 3650-23970; 3650-24518; 3650-23477; 3650-23507; 3650-24331; 3650-24396; 3650-24486; 3650-25301
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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