Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesion
FDA device recall Z-1878-2008 · posted 2008-09-25 · Terminated
Recall details
- Recalling firm
- Medical Device Technologies, Inc.
- Reason for recall
- The sterility of the product cannot be guaranteed.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GAA
- Quantity affected
- 490 units.
- Distribution
- Nationwide and to Mexico.
- Date initiated
- 2008-05-06
- Date posted
- 2008-09-25
- Date terminated
- 2011-11-10
- Location
- Gainesville, FL
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