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.
FDA Recall Z-2819-2015 · Posted 2015-09-28
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Recalling FirmSTERILMED, INC.
Recall StatusTerminated
Product CodeKCY
Date Initiated2015-08-24
Date Terminated2016-03-11
Product Quantity43
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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