Recall Z-1878-2008 ยท GAA Needle, Aspiration And Injection, Disposable
Medical Device Technologies, Inc.
Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
| Date | Sep 25, 2008 (initiated May 6, 2008) |
| Status | Terminated |
| Reason | The sterility of the product cannot be guaranteed. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 490 units. |
| Distribution | Nationwide and to Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.