Reported Oct 7, 2015 · Terminated
Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor)…
Sterilmed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: STERILMED, INC. · 11400 73rd Ave N · Maple Grove, MN · 55369-5561
Is this the product you have?
- Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34"
- Model (Reprocessor) NumberZIM60-7075-106, 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
- Lot codes and dates
- Lot 1846885
- Amount recalled
- 43
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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