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U.S. Department of Health and Human Services

Class 2 Device Recall Hawkins III (BLN) Breast Localization Needle

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  Class 2 Device Recall Hawkins III (BLN) Breast Localization Needle see related information
Date Initiated by Firm May 06, 2008
Date Posted September 25, 2008
Recall Status1 Terminated 3 on November 10, 2011
Recall Number Z-1878-2008
Recall Event ID 48623
Product Classification Needle - Product Code GAA
Product Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
Code Information Lot #; 80281L5V
Recalling Firm/
Manufacturer		 Medical Device Technologies, Inc.
3600 SW 47th Ave
Gainesville FL 32608-7555
For Additional Information Contact
352-338-0440 Ext. 350
Manufacturer Reason
for Recall		 The sterility of the product cannot be guaranteed.
FDA Determined
Cause 2		 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 in Commerce 490 units.
Distribution Nationwide and to Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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