Reported Dec 16, 2015 · Terminated
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
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, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
- Lot codes and dates
- All lot numbers with expiration dates 2016-07 or prior. Lot Number
3,615 of 3,615 codes
172000917578541758629176864617744121784664178662617959111797605180071418016761802271180547218073441807744180901118091841809195180991018100631812006181231218123651812545181256118125671812740181288318131411813511181395918140401814199181421918142231814231181465118146711814751181498918152201815362181537118154161815427181559118156111815908181618218161861816268181626918165111816512181651318165141816516181655818167191816734
- All lot numbers with expiration dates 2016-07 or prior. Lot Number
- Amount recalled
- 174,960
Where it was sold
- Nationwide
Why it was recalled
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
This product could cause temporary or reversible health problems — stop using it.
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