| Class 2 Device Recall Wallach Cryotip | |
Date Initiated by Firm | June 06, 2007 |
Date Posted | July 11, 2007 |
Recall Status1 |
Terminated 3 on July 15, 2015 |
Recall Number | Z-1046-2007 |
Recall Event ID |
38072 |
510(K)Number | K803311 |
Product Classification |
Cryosurgical instrument - Product Code GEH
|
Product | Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X
Reference: 900220 |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Wallach Surgical Devices, Inc. 235 Edison Road Orange CT 06477-3603
|
For Additional Information Contact | Gary LeMere 203-799-2000 |
Manufacturer Reason for Recall | The tip may separate from the probe. |
FDA Determined Cause 2 | 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 in Commerce | 14 units |
Distribution | Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = GEH
|
|
|
|