Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Reported: February 24, 2021 Initiated: December 23, 2020 #Z-1114-2021
Product Description
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Reason for Recall
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Details
- Recalling Firm
- Combat Medical Systems, LLC
- Units Affected
- 954 units
- Distribution
- US Nationwide Distribution
- Location
- Harrisburg, NC
Frequently Asked Questions
What product was recalled? ▼
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.. Recalled by Combat Medical Systems, LLC. Units affected: 954 units.
Why was this product recalled? ▼
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2021. Severity: Critical. Recall number: Z-1114-2021.
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