Device product
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.
Z-2819-2015
Product summary
- Firm
- STERILMED, INC.
- Event
- Event 72035
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43
- Official record key
device-enforcement:Z-2819-2015
Official wording
Reason: 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.
Code information: Lot 1846885
Distribution pattern: US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
Derived failure modes
-
Labeling or packaging
mislabeling