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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed Zimmer Tourniquet Cuffs

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  Class 2 Device Recall Reprocessed Zimmer Tourniquet Cuffs see related information
Date Initiated by Firm August 24, 2015
Date Posted September 28, 2015
Recall Status1 Terminated 3 on March 11, 2016
Recall Number Z-2819-2015
Recall Event ID 72035
Product Classification Tourniquet, pneumatic - Product Code KCY
Product Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed.

Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
Code Information Lot 1846885
Recalling Firm/
Manufacturer		 STERILMED, INC.
11400 73rd Ave N
Maple Grove MN 55369-5561
For Additional Information Contact Sterilmed Customer care Team
888-541-0078
Manufacturer Reason
for Recall		 Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Sterilmed sent an "Urgent Medical Device Recall" letter dated August 24 2015. The letter was addressed to Materials Manger, Risk Manger and Operating Room Supervisor. The letter identified the affected product, problem and actions to be taken. Customers are requested to return all affected product, sign and return the enclosed Customer Response Questionnaire and the Customer Response Form per the instructions on the Forms. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
Quantity in Commerce 43
Distribution US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
Total Product Life Cycle TPLC 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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