Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty

FDA device recall Z-2022-2010 · posted 2010-07-13 · Terminated

Recall details

Recalling firm

Medical Device Technologies, Inc.

Reason for recall

Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.

Action taken

Angiotech sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated September 1, 2009, to all customers. on September 2, 2009 by UPS 2nd day delivery with an assigned tracking number. The letter described the product, problem and action to be taken by customers. The customers were instructed to please review your current inventory and segregate the affected lot numbers, complete the attached Customer Acknowledgement Form and return via fax to our Quality Assurance department at 1-352-338-0662 or 1-800-333-0440. If you are a distributor of this product, you are responsible for notifying any customer you may have sold the product to. If you have any questions concerning this notification, please contact Shannon Brooks at (352) 338-0440 ext.355 or Katrenia Williams at ext. 353.

Root cause

Other

Status

Terminated

Product code

IWJ

Quantity affected

4,180

Distribution

Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC,

Date initiated

2009-09-01

Date posted

2010-07-13

Date terminated

2011-02-25

Location

Gainesville, FL

Related 510(k) clearances