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
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Product | MAMMOGRAPHY |
Code Information |
Catalog No. LGHM022-02 , LOT# 1021706 |
Recalling Firm/ Manufacturer |
Avid Medical, Inc. 9000 Westmont Dr Toano VA 23168-9351
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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 |
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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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