Sterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns
Sterilmed is voluntarily recalling reprocessed tourniquet cuffs because the company cannot assure the sterility of all units in the affected lots.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of infection from non-sterile medical devices in a sterile operative field, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. The recall involves 174,960 units of the Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon, which were reprocessed by Sterilmed and sterilized with Ethylene Oxide (EO). The affected units are distributed nationwide in the United States and include all lot numbers with expiration dates of July 2016 or prior.
The recall is being conducted because 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 related to this issue.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact Sterilmed, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
- Manufacturer
- STERILMED, INC.
- Affected units
- 174,960
Distribution
Distributed nationwide across the United States.
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