FDA-Device2015-10-07Class II
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.
STERILMED, INC.
Hazard
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.
Sold states
US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
Affected count
43
Manufactured in
11400 73rd Ave N, N/A, Maple Grove, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2819-2015Don't want to check this manually?
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