Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue.
FDA Recall Z-1698-2008 · Posted 2008-09-03
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Recalling FirmGalil Medical
Recall StatusTerminated
Product CodeGEH
Date Initiated2007-12-11
Date Terminated2008-09-02
Product Quantity541 catheters
Reason for Recall
The warming catheter was manufactured with the inlet and outlet tubes switched.
Firm Action
The recalling firm telephoned their customers in April 2008 to inform them of the problem and the need to return the product. There customers were also asked to contact the firm if they had actually used any of the kits with the serial numbers listed, even if they experienced no problem. As a follow up to the telephone call, a letter was issued to the customers. For assistance, please call 770-565-6166.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and country of Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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