Recall Z-0832-2011 ยท GEH Unit, Cryosurgical, Accessories
Galil Medical
Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
| Date | Dec 29, 2010 (initiated Nov 11, 2010) |
| Status | Terminated |
| Reason | This voluntary recall has been initiated because our supplier (Gaymar Industries, Inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. Affected plugs can be identified by a round ground pin and black plastic bridges. Cords with plugs that are not affected have U-shaped ground pins and no plastic bridges. Although Gali |
| Root cause | Other |
| Action | Gaymar sent an URGENT: MEDICAL DEVICE RECALL letter dated September 30, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Customers were instructed to: " Inspect units in their possession to determine if they contain affected power cord plugs or if there were any signs of excessive wear or damage. " Immediately discontinue use and quarantine the affected product. " Contact Customer Service Department at 800-828-7341 to arrange for replacement. " Complete the attached form for each unit |
| Quantity | 4 |
| Distribution | Worldwide Distribution - USA, including CA, GA, TX and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010991 | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 Galil Medical , Ltd., May 3, 2001 |