Recall Z-1113-2021— Combat Medical Systems, LLC
Class I · Terminated
Class I FDA medical device recall by Combat Medical Systems, LLC, initiated 2020-12-23, terminated 2024-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.. Reason: 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
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2020-12-23
- Terminated
- 2024-07-09
- Firm location
- Harrisburg, NC, United States
Product description
Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
Reason for recall
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.