Class 2 Device Recall SafeSheath KR under the Pressure Products label

• Date Initiated by Firm: October 14, 2004
• Date Posted: October 28, 2004
• Recall Status: Terminated on January 24, 2006
• Recall Number: Z-0056-05
• Recall Event ID: 30242
• 510(K)Number: K934901
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units
• Code Information: Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06, and Lot number F6251 exp. 6/06
• Recalling Firm/ Manufacturer: Thomas Medical Products Inc; 65 Great Valley Pkwy; Malvern PA 19355-1302
• For Additional Information Contact: Peter J. Rapp; 610-296-3000
• Manufacturer Reason for Recall: Sheaths may fracture if exposed to excess fluorescent light
• FDA Determined Cause: Other
• Action: The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall.
• Quantity in Commerce: 1170 kits
• Distribution: The product was shipped to the label owner/distributor in CA.
• 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.

• 510(K) Database: 510(K)s with Product Code = DYB