FDA MedWatch - Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set by Combat Medical Systems:

Class I Recall - Due to Possible Broken or Bent Needles

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set by Combat Medical Systems: Class I Recall - Due to Possible Broken or Bent Needles AUDIENCE: Patient, Health Professional, Risk Manager, Hematology, Phlebotomy ISSUE: 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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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. RECOMMENDATIONS:  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). Do not use any convenience kit with a bent or disconnected needle. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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