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.
Recall
- Recall Number
- Z-1698-2008
- Event Number
- 47888
- Firm
- Galil Medical
- FEI Number
- 3004462490
- Product Code
- GEH
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 11, 2007
- Posted
- September 3, 2008
- Terminated
- September 2, 2008
- Address
- 401 Plymouth Rd, Ste 130, Plymouth Meeting, PA, 19462-1651
Description
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.
The warming catheter was manufactured with the inlet and outlet tubes switched.
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.
Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and country of Canada
541 catheters