Class 2 Device Recall Mallinckrodt Launcher Guiding Catheter

• Date Initiated by Firm: April 04, 2016
• Create Date: May 09, 2016
• Recall Status: Terminated on July 13, 2016
• Recall Number: Z-1626-2016
• Recall Event ID: 73835
• 510(K)Number: K082520
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
• Code Information: Lot #481938U
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: 888-888-3433
• Manufacturer Reason for Recall: Device packaging may not be sealed.
• FDA Determined Cause: Process control
• Action: Customer notification letter was sent 04/04/2016. The customer was provided the following instructions: Use of the affected lots of the recalled product should be discontinued. A Recall Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility. Once inventory has been checked complete the Recall Effectiveness Check Form. The form needs to be completed even if no affected product is found. Return the completed and signed Recall Effectiveness Check Form utilizing one of the following methods: Return to your local Stryker Sustainability Sales Representative Email to ssspfa@stryker.com, or Mail to: Stryker Sustainability Solutions 181 O West Drake Drive Tempe, AZ. 85283 Attn: Jodie Rueckert If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 http://www.stryker.com/productexperience/ The FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
• Quantity in Commerce: 2
• Distribution: US distribution to KY.
• 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 = BTR