| Class 2 Device Recall | |
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 |
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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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