Recall Z-1046-2007 ยท GEH Unit, Cryosurgical, Accessories
Wallach Surgical Devices, Inc.
Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
| Date | Jul 11, 2007 (initiated Jun 6, 2007) |
| Status | Terminated |
| Reason | The tip may separate from the probe. |
| Root cause | Device Design |
| Action | Wallach Surgical notified accounts by fax on 6/6/07. A follw-up telephone call will be made to the 70 domestic consignees. Foreign consignees notiifed by fax or email with follow-up telephone calls. Accounts are requested to return product and replace with an alternate product. |
| Quantity | 14 units |
| Distribution | Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K803311 | LL100 CRYOSURGICAL SYSTEM Wallach Surgical Devices, Inc., Feb 4, 1981 |