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
Combat Medical is recalling the convenience kits because the needle in the blood pack may bend or disconnect from the blood bag tubing. The possible needle damage only occurs during the packaging process before being received by the user. If this happens, a bent or disconnected needle could potentially result in injury at the donor site or delay and inability to treat patients by giving needed blood.
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.
Questions?
If you have questions about this recall, contact the Division of Industry and Consumer Education.
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