Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-C

FDA device recall Z-0025-2011 · posted 2010-10-08 · Terminated

Recall details

Recalling firm

Medical Device Technologies, Inc.

Reason for recall

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

Action taken

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 Brooks at (352) 338-0440 ext 355 or Katrenia Williams at ext 353.

Root cause

Other

Status

Terminated

Product code

MJG

Quantity affected

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 Af

Date initiated

2010-07-02

Date posted

2010-10-08

Date terminated

2011-06-28

Location

Gainesville, FL

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