Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set for Possible Broken or Bent Needles
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Combat Medical Convenience Kits:
- Valkyrie LTOWB Collection and Administration
- Models: 80-820, NSN 6515016862423 and 80-821 NSN 6515016862401
- Low Titer Type O FWB Transfusion Set and Low Titer Type O Donor Collection Set
- Models: 80-875 NSN 651501684994 and 80-875-D
- Fresh Whole Blood Transfusion Set and Fresh Whole Blood Donor Set
- Models: 80-801 NSN 6515016574750 and 80-801-D NSN 6515016640306
- Lot Numbers: Please See Links Below
- Distribution Dates: July 1, 2019 to November 30, 2020
- Devices Recalled in the U.S.: 30,549
- Date Initiated by Firm: December 23, 2020
The convenience kits under recall are used by military medical personnel to get and transfuse donor blood to patients on the battlefield. Each kit has a blood bag with a needle attached and includes other components to screen blood.
Reason for Recall
Combat Medical is recalling the convenience kits because the needle in the blood pack may bend or disconnect from the blood bag. The possible needle damage only occurs during the packaging process before being received by the user. However, a user will not be able to identify if the needle is damaged until the pack has been opened for use.
A bent/disconnected needle could potentially result in:
- Bruising or hematoma (an area of clotted blood under the skin).
- Delay, change, or inability to treat patients by giving needed blood, which may lead to injury or death.
There have been four complaints about this device issue. There have been no reports of injuries or deaths.
Who May be Affected
- Health care providers using the affected Combat Medical convenience kits.
- Blood Donors or patients who require care using the Combat Medical convenience kits.
What to Do
On December 22, 2020, Combat Medical sent an Urgent Medical Device Recall Notice letter to all affected customers and distributors. The letter gave information on how to spot needle damage and the following information:
- Remove all affected convenience kits from use.
- Return the affected kit to Combat Medical with a copy of a completed Recall Acknowledgement and Receipt Form (included in the letter from the firm).
The FDA also recommends that you do not use any convenience kit with a bent or disconnected needle.
Customers with questions about this recall should contact:
Kimberly Reed, Director Global Regulatory Affairs (Recall coordinator)
5555 Harrisburg Parkway
Harrisburg, NC, 28075
Full List of Affected Devices
Note: 80-801-D Part Number is both a subassembly (that is consumed into the 80-801) and finished good part number. 26,553 were used to build 80-801 finished goods.
- Recall Database Entry
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.