Z-2819-2015 Class II Terminated
FDA device recall Z-2819-2015 was initiated by STERILMED, INC. on August 24, 2015 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated March 11, 2016). Affected quantity: 43.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2015
- Initiation Date
- August 24, 2015
- Termination Date
- March 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
Code Information
Lot 1846885