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Terminated

Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

FDA Recall Z-2016-2010 · Posted 2010-07-13

Recalling FirmMedical Device Technologies, Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2009-09-01
Date Terminated2011-02-25
Product Quantity52,020

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.

Firm Action

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

Distribution Pattern

Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980226MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEMMedical Device Technologies, Inc. · 1998-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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