Class 2 Device Recall Mallinckrodt SatinSlip Intubating Stylet

• Date Initiated by Firm: July 12, 2006
• Date Posted: August 24, 2006
• Recall Status: Terminated on January 10, 2007
• Recall Number: Z-1431-06
• Recall Event ID: 35879
• Product Classification: Stylet - Product Code BSR
• Product: Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
• Code Information: Model number 85863 (size 6 French), all lot codes beginning in 05 and 06
• Recalling Firm/ Manufacturer: Nellcor Puritan Bennett; 4280 Hacienda Dr; Pleasanton CA 94588-2719
• Manufacturer Reason for Recall: Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation.
• FDA Determined Cause: Other
• Action: The firm has issued notification letters via USPS certified mail with return receipt, requesting that the recipients who have further distributed the product forward a copy of that letter. The firm intends to contact non-responding companies beginning 30 days after the initial notification is sent.
• Quantity in Commerce: 30,366 cases of 20 units per case were distributed worldwide
• Distribution: The product has been distributed to 454 consignees throughout the United States, Guam and Japan.
• 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.