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.