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U.S. Department of Health and Human Services

Class 1 Device Recall Valkyrie LTOWB Administration

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 Class 1 Device Recall Valkyrie LTOWB Administrationsee related information
Date Initiated by FirmDecember 23, 2020
Date PostedFebruary 19, 2021
Recall Status1 Terminated 3 on July 09, 2024
Recall NumberZ-1111-2021
Recall Event ID 87084
Product Classification Blood transfusion kit - Product Code POQ
ProductValkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.
Code Information Lot Numbers: MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, MFG3698
Recalling Firm/
Manufacturer		 Combat Medical Systems, LLC
5555 Harrisburg Ind Pk Dr
Harrisburg NC 28075-7407
For Additional Information ContactKimberly Reed
855-428-6074
Manufacturer 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 2		Process control
ActionThe 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.
Quantity in Commerce953 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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