Z-2015-2010

Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE...

Name: Z-2015-2010 Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE...
Creator: Medical Device Technologies, Inc.
Published: 2009-09-01
License: https://open.fda.gov/license/

Medical Device Technologies, Inc. / initiated 2009-09-01 / Terminated / root cause: packaging

FDA source

Medical Device Technologies, Inc. began a recall of Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103... on 2009-09-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2015-2010
Status: Terminated
Initiated: 2009-09-01
Posted: 2010-07-13
Terminated: 2011-02-25
Recalling firm: Medical Device Technologies, Inc.
Product: Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle
Product code: GDM Needle, Aspiration And Injection, Reusable
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.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 58,670
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, 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.
Product codes and lots: A) 90621SZN, 91051TTN, 91591UV4, 90571SVW, 90571SVX, 90681T3E, 90911TK7, 91181TW9, 91271U9Y, 91561UU6, 90571SUJ, 90571SUK, 90681T46, 90831TA6, 90921TKY, 90961TLT, 91051TTS, 91131TZD, 91131U08, 91201U5P, 91471UNO, 91541US2, 91631UZT, 90891TGR, 90701T5A, 90961TM1, 91031TM2, 91341UF3, 91481UO9, 90751T6X, 90751T6Y, 91051TTL, 91131TZ7, 91541US1, 91551UT0, 90491SOM, 90821T2V, 91061TTU, 91121TXX, 91041TOI . B) 90551STU, 91461ULZ, 91491UPP, 90551STT, 90681T42, 90921TKW, 90901TIZ, 91561UTY, 90541SRB, 91171TW7, 91311UBE, 90681T3N, 91311UBF, 91481UOA, 90541SS4, 90701T5G, 90971TOJ, 91171U2A, 91461UMQ, 90611SY7, 90891TH1, 91131TZT, 91471UNJ. C) 91331UCJ, 90571SW1, 90641T1V, 91181U2T, 90551SUD, 90611SXX, 90901TJ3, 91271U9X, 91461UML, 90571SUV, 90821TCM, 90961TM3, 91411UKL, 90551SUE, 90641T1W, 90821TCN, 91061TUI, 91341UFK, 91461UMK, 91681V2T, 90611SXV, 90701T5M, 91131TZK, 91271U9V, 90641T22, 90681T39, 90681T3A, 90771T9T, 90821TCW, 90901TIK, 90971TNO, 91051TTT, 91271UA4, 91331UCR, 90551SU9, 90551SUA, 90571SVT, 90771TAE, 90891THJ, 91061TUP, 91331UCQ, 91471UNM, 91551UT2, 91741V6K. D) 90411SIV, 90541SSU, 90641T1Y, 91131TZS, 90541SRF, 90631T0Z, 90751T7Q, 90841TEE, 91031TRX, 91271UA0, 91341UFS, 91391UHY, 90541SSD, 90781TBI, 90901TJA, 91271TUQ, 91491UPH, 91551UT3, 90901TJ8, 91561UU7, 90981TPU, 91131TZU. E) 90611SYG, 91131TZB.

Product code GDM

K870523Class IHawkins Breast Localization NeedleN-S Medical Products / cleared 1987-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)