Recall Z-2819-2015— STERILMED, INC.
Class II · Terminated
Class II FDA medical device recall by STERILMED, INC., initiated 2015-08-24, terminated 2016-03-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- STERILMED, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-24
- Terminated
- 2016-03-11
- Firm location
- Maple Grove, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.