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Terminated

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

FDA Recall Z-0404-2016 · Posted None

Recalling FirmSTERILMED, INC.
Recall StatusTerminated
Product CodeKCY
Date Initiated2015-11-13
Date Terminated2016-12-12
Product Quantity174,960

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.

Firm Action

Consignees were sent a Sterilmed "Urgent Medical Device Recall: letter dated November 13, 2015. The letter was addressed to Materials Manager, Risk Manager and Operating Room Director. The letter described the product affected, the description of the problem and the Actions Required. Requested consignees to quarantine and return affected product and to complete and return the Business Reply Form. For questions contact Sterilmed's Customer Care Team at 888-541-0078.

Root Cause

Process control

Distribution Pattern

US: Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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