Recall Z-2018-2010
Medical Device Technologies, Inc. · initiated September 1, 2009
Product
Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE. Product Number: MPCN1802. 510k K974745. Qty Dist. - 425. B) "Seldinger" Needle. STERILE. Product Number: SN1802, SN1902. 510k K974745. Qty Dist. - 5,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Vascular Access Needle
Codes / lots: A) 90821TCC. B) 90621SZO, 90981TPN, 91311UB7, 91391UHR, 90621T00, 91201U63, 91541URU .
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-2018-2010
- Initiated
- September 1, 2009
- Posted by FDA
- July 13, 2010
- Terminated
- February 25, 2011
- Product code
- DRC – Trocar
- Quantity
- 5,675
- 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…
- Recalling firm
- Medical Device Technologies, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2015-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2016-2010 | Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2017-2010 | Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2019-2010 | Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2020-2010 | Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2021-2010 | Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2022-2010 | Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2023-2010 | Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number:…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |
| Z-2024-2010 | Angiotech Needle Guide. Needle Guide for Lorad Stereo Loc. STERILE. Product Number:…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | 09/01/2009Terminated |