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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 October 05, 2015
Date Posted August 18, 2016
Recall Status1 Terminated 3 on January 10, 2017
Recall Number Z-2592-2016
Recall Event ID 73465
Product Classification General surgery tray - Product Code LRO
Product MAMMOGRAPHY
Code Information Catalog No. LGHM022-02 , LOT# 1021706
Recalling Firm/
Manufacturer		 Avid Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information Contact Larry Bogues
757-566-3510
Manufacturer Reason
for Recall		 Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
FDA Determined
Cause 2		 Employee error
Action Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 cm) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Quantity in Commerce 200
Distribution Recalled product was distributed to 2 states: Virginia and Massachusetts.
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.
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