Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Reported: December 16, 2015 Initiated: November 13, 2015 #Z-0404-2016
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.
Details
- Recalling Firm
- STERILMED, INC.
- Units Affected
- 174,960
- Distribution
- US: Nationwide
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.. Recalled by STERILMED, INC.. Units affected: 174,960.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2015. Severity: Moderate. Recall number: Z-0404-2016.
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