| Class 2 Device Recall AVID TruCustom | |
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/ 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 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 |
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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.
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