FDAFDA · Food and drugs·Recall number Z-2819-2015
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.
Published October 7, 2015 · Recall initiated: August 24, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- STERILMED, INC.
- Distributor
- US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
- Lot
- Lot 1846885
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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