FDA-Device2015-12-16Class II
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
STERILMED, INC.
Hazard
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.
Sold states
US: Nationwide
Affected count
174,960
Manufactured in
11400 73rd Ave N, N/A, Maple Grove, MN, United States
Products
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0404-2016Don't want to check this manually?
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