Recall Z-0025-2011 ยท MJG Device, Percutaneous, Biopsy
Medical Device Technologies, Inc.
Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 0109
| Date | Oct 8, 2010 (initiated Jul 2, 2010) |
| Status | Terminated |
| Reason | Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to compromised packaging integrity. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recall is for the following Model Numbers: 763114100X, 763114160X, 763114 |
| Root cause | Other |
| Action | Angiotech sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated July 2, 2010 and response card to all customers including distributors. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review their current inventory and segregate the affected lot numbers; arrange for return and replacement of the affected product, and complete and return the Customer Acknowledgment Form via fax to the Quality Assurance department at 1-352-338-0662 or 1-800-333-0440. If you have any questions concerning this notification, contact Shannon |
| Quantity | 11,123 boxes (111,230 units) |
| Distribution | Worldwide distribution: USA and countries including: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Israel, Japan, New Zealand, Peru, South Africa, , Uruguay, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982960 | MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT Medical Device Technologies, Inc., Sep 23, 1998 |