Date Initiated by Firm |
May 05, 2005 |
Date Posted |
June 01, 2005 |
Recall Status1 |
Terminated 3 on May 08, 2012 |
Recall Number |
Z-0858-05 |
Recall Event ID |
32076 |
510(K)Number |
K923127
|
Product Classification |
Needle, Hypodermic, Single Lumen - Product Code FMI
|
Product |
Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238 |
Code Information |
Lot Number: K621494 |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 10 Bowman Dr Keene NH 03431-5043
|
For Additional Information Contact |
Timothy Talcott 603-352-3812 Ext. 2457
|
Manufacturer Reason for Recall |
Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"
|
FDA Determined Cause 2 |
Other |
Action |
Smith Medical notified dealers of the recall on May 5, 2005 by telephone. The remaining customers were notified on May 12, 2005 by telephone. Follow-up letter delivered by Federal Express on May 17, 2005. |
Quantity in Commerce |
159 cases (400 per case) =63,600 each. |
Distribution |
Nationwide |
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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