Recall Z-0404-2016— STERILMED, INC.
Class II · Terminated
Class II FDA medical device recall by STERILMED, INC., initiated 2015-11-13, terminated 2016-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.. Reason: Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue..
- Recalling firm
- STERILMED, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-13
- Terminated
- 2016-12-12
- Firm location
- Maple Grove, MN, United States
Product description
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Reason for recall
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.