Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218
FDA device recall Z-1045-2007 · posted 2007-07-11 · Terminated
Recall details
- Recalling firm
- Wallach Surgical Devices, Inc.
- Reason for recall
- The tip may separate from the probe.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 315 units
- Distribution
- Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania
- Date initiated
- 2007-06-06
- Date posted
- 2007-07-11
- Date terminated
- 2015-07-15
- Location
- Orange, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LL100 CRYOSURGICAL SYSTEM (K803311) | Wallach Surgical Devices, Inc. | 1981-02-04 |