Date Initiated by Firm |
April 09, 2007 |
Date Posted |
April 21, 2007 |
Recall Status1 |
Terminated 3 on August 07, 2007 |
Recall Number |
Z-0767-2007 |
Recall Event ID |
37759 |
Product Classification |
Scalpel - Product Code GES
|
Product |
Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels. |
Code Information |
Part number 4-422, Lot number S07A10 |
Recalling Firm/ Manufacturer |
Miltex, Inc. 589 Davies Drive York PA 17402-8630
|
For Additional Information Contact |
Audie D. Margrave 866-854-8400
|
Manufacturer Reason for Recall |
Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued a recall letter dated 4/9/07 informing the customers of the problem and the need to return the product. The letter was sent via UPS with a return receipt required to verify delivery. Distributors were notified to sub-recall. |
Quantity in Commerce |
400 boxes |
Distribution |
Nationwide to distributors in CA, FL, IA, ID, NM, NJ, OH, PA, RI, and VA. |
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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