Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. Th...
FDA Recall #Z-1112-2021 — Class I — December 23, 2020
Product Description
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
Reason for Recall
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Recalling Firm
Combat Medical Systems, LLC — Harrisburg, NC
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1021 units
Distribution
US Nationwide Distribution
Code Information
Lot Numbers: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated