Class 2 Device Recall Miltex Stainless Steel Disposable Scalpel

• Date Initiated by Firm: April 09, 2007
• Date Posted: April 21, 2007
• Recall Status: Terminated 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
• FEI Number: 2518040
• 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: 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

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.