Class 2 Device Recall SafeSheath

• Date Initiated by Firm: June 11, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 27, 2005
• Recall Number: Z-1086-04
• Recall Event ID: 29395
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton.
• Code Information: All lot numbers are affected.
• 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 Ext. 214
• Manufacturer Reason for Recall: Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
• FDA Determined Cause: Other
• Action: The recalling firm send a recall letter via fax and Federal Express 6/11/2004 to the various wholesalers and/or distributors informing them of the recall and to return all product to the recalling firm.
• Quantity in Commerce: 39,605 kits
• Distribution: The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.
• 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.