Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fr...
FDA Device Recall #Z-1114-2021 - Class I, December 23, 2020
Recall Summary
| Recall Number | Z-1114-2021 |
| Classification | Class I - Serious risk |
| Date Initiated | December 23, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Combat Medical Systems, LLC |
| Location | Harrisburg, NC |
| Product Type | Devices |
| Quantity | 954 units |
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.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857
Other Recalls from Combat Medical Systems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1110-2021 | Class I | Valkyrie LTOWB Collection (P/N 80-820, NSN 6515... | Dec 23, 2020 |
| Z-1113-2021 | Class I | Fresh Whole Blood Transfusion Set (P/N 80-801 N... | Dec 23, 2020 |
| Z-1111-2021 | Class I | Valkyrie LTOWB Administration (P/N 80-821 NSN 6... | Dec 23, 2020 |
| Z-1112-2021 | Class I | Low Titer Type O FWB Transfusion Set (P/N 80-87... | Dec 23, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.