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U.S. Department of Health and Human Services

Class 2 Device Recall AVID TruCustom

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  Class 2 Device Recall AVID TruCustom see related information
Date Initiated by Firm June 22, 2017
Create Date February 28, 2018
Recall Status1 Terminated 3 on October 12, 2018
Recall Number Z-0796-2018
Recall Event ID 79162
Product Classification General surgery tray - Product Code LRO
Product AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06

Code Information Lot, Expiration Date: 1198253, 9/1/2018; 1213945, 7/1/2018           
Recalling Firm/
Avid Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information Contact Darcy Sisson
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 2
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 90
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.