Recall Z-1878-2008
Medical Device Technologies, Inc. · initiated May 6, 2008
Product
Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
Codes / lots: Lot #; 80281L5V
Reason for recall
The sterility of the product cannot be guaranteed.
FDA-determined cause: Employee error
Action taken
The firm sent a letter to its consignees on 5/6/08, informing of the recall and requesting that they complete and return by fax the attached customer acknowledgement form. For assistance, contact Medical Device Technologies, Inc., dba Angiotech at 1-352-338-0440 ext. 350 or ext. 353.
Details
- Recall number
- Z-1878-2008
- Initiated
- May 6, 2008
- Posted by FDA
- September 25, 2008
- Terminated
- November 10, 2011
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Quantity
- 490 units.
- Distribution
- Nationwide and to Mexico.
- Recalling firm
- Medical Device Technologies, Inc., Gainesville, FL