Date Initiated by Firm |
October 05, 2015 |
Date Posted |
August 18, 2016 |
Recall Status1 |
Terminated 3 on January 10, 2017 |
Recall Number |
Z-2591-2016 |
Recall Event ID |
73465 |
Product Classification |
General surgery tray - Product Code LRO
|
Product |
PEDIATRIC KIDNEY BIOPSY TRAY |
Code Information |
Catalog No. MCVA0091-01 , LOT# 1029428 |
Recalling Firm/ Manufacturer |
Avid Medical, Inc. 9000 Westmont Dr Toano VA 23168-9351
|
For Additional Information Contact |
Larry Bogues 757-566-3510
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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.
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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 |
20 |
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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