Class 2 Device Recall AVID TruCustom

• Date Initiated by Firm: June 22, 2017
• Create Date: February 28, 2018
• Recall Status: Terminated on October 12, 2018
• Recall Number: Z-0783-2018
• Recall Event ID: 79162
• Product Classification: General surgery tray - Product Code LRO
• Product: AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
• Code Information: Lot, Expiration Date: 1198747, 11/1/2018; 1199952, 10/1/2018; 1219974, 1/1/2019
• Recalling Firm/ Manufacturer: Avid Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Darcy Sisson; 828-338-7568
• Manufacturer Reason for Recall: Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An email notification was sent to all sales representatives with the BD recall notification and the following instructions: " Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. " All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited. " Label Quantity- 1 for each affected tray, plus 1 for each outside carton. " Contact Name " Address " Phone Number Sales representatives were asked to confirm to QualityAssurance@owens-minor.com that your customers were notified.
• Quantity in Commerce: 70
• Distribution: Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
• 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.