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Recall Observatory FDA recall evidence

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

August 24, 2015

Class II

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

    reason.labeling_packaging · v1.0.0

    mislabeling