Recall Z-1698-2008 ยท GEH Unit, Cryosurgical, Accessories
Galil Medical
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.
| Date | Sep 3, 2008 (initiated Dec 11, 2007) |
| Status | Terminated |
| Reason | The warming catheter was manufactured with the inlet and outlet tubes switched. |
| Root cause | Process control |
| 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. |
| Quantity | 541 catheters |
| Distribution | Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012497 | CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 Galil Medical , Ltd., Oct 30, 2001 |