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U.S. Department of Health and Human Services

Class 2 Device Recall Miltex Stainless Steel Disposable Scalpel

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 Class 2 Recall
Miltex Stainless Steel Disposable Scalpel
see related information
Date Posted April 21, 2007
Recall Status1 Terminated on August 07, 2007
Recall Number Z-0767-2007
Recall Event ID 37759
Product Classification Blade, 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, Pennsylvania 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
PRODUCTION CONTROLS: Process Control
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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