Recall Z-1110-2021
Combat Medical Systems, LLC · initiated December 23, 2020
Class I – dangerous or defective products that could cause serious health problems or death
Product
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.
Codes / lots: Lot Numbers: MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, MFG3671
Reason for recall
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
FDA-determined cause: Process control
Action taken
The firm, Combat Medical, sent an "URGENT: MEDICAL DEVICE RECALL (# 20-PR-002)" letter dated 12/22/2020 initiating the recall to its customers by email on 12/23/2020. The letter described the product, problem and actions to be taken. The customer was instructed to do the following: Remove the Convenience Kits from all points of use and return to Combat Medical for replacement. Please also complete the attached Recall Acknowledgement and Receipt Form and return it by email: recalls@combatmedical.com or by mail to: Combat Medical , Attn: Recall Coordinator, 5555 Harrisburg Parkway, Harrisburg, NC 28075. Do not use any Convenience Kit found to have a bent or disconnected needle. Upon return of the product, Combat Medical will issue a replacement or credit for each returned kit. Questions directly associated with this recall should be directed to the Director Global Regulatory Affairs (Recall Coordinator), telephone: 855-428-6074 or by email: recalls@combatmedical.com.
Details
- Recall number
- Z-1110-2021
- Initiated
- December 23, 2020
- Posted by FDA
- February 19, 2021
- Terminated
- July 9, 2024
- Product code
- POQ – Blood Transfusion Kit
- Quantity
- 531 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Combat Medical Systems, LLC, Harrisburg, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1111-2021 Class I | Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 12/23/2020Terminated |
| Z-1112-2021 Class I | Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 12/23/2020Terminated |
| Z-1113-2021 Class I | Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 12/23/2020Terminated |
| Z-1114-2021 Class I | Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit.…There is the potential of a bent or disconnected needle in one of the components of the convenience kits. | 12/23/2020Terminated |