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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 04, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 29, 2004
Recall Number Z-0570-04
Recall Event ID 27709
Product Classification Needle, Tumor Localization - Product Code MIJ
Product Template Needle, Series 17, 20 cm, with Threaded Female hub and Bent Stylet, Closed-End, Disposable.

Packaged in single, 10, 15, 20 per package.
Code Information Lots F01068, F01099, F01100, F01128.
Recalling Firm/
Manufacturer		 Alpha-Omega Services Inc
9156 Rose St
Bellflower CA 90706-6420
For Additional Information Contact Bob A. Robnett
562-804-0604
Manufacturer Reason
for Recall		 Template needle may fracture leaving tip in patient.
FDA Determined
Cause 2		 Other
Action A fax of the recall notice was made on 9/4/2003 and a follow-up telephone call was made. This recall is complete.
Quantity in Commerce 1330
Distribution LA, MN, CA, VA, CO, TX, ID, NY, KS, WA
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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