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Terminated

Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.

FDA Recall Z-1878-2008 · Posted 2008-09-25

Recalling FirmMedical Device Technologies, Inc.
Recall StatusTerminated
Product CodeGAA
Date Initiated2008-05-06
Date Terminated2011-11-10
Product Quantity490 units.

Reason for Recall

The sterility of the product cannot be guaranteed.

Firm 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.

Root Cause

Employee error

Distribution Pattern

Nationwide and to Mexico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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