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U.S. Department of Health and Human Services

Class 2 Device Recall AVID Medical QA Pack

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  Class 2 Device Recall AVID Medical QA Pack see related information
Date Initiated by Firm July 03, 2017
Create Date February 09, 2018
Recall Status1 Terminated 3 on April 17, 2018
Recall Number Z-0581-2018
Recall Event ID 79135
Product Classification General surgery tray - Product Code LRO
Product AVID Medical QA Pack AV10654-10
Code Information Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)
Recalling Firm/
Manufacturer		 Avid Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information Contact Sharon Moll
757-566-9844
Manufacturer Reason
for Recall		 The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
FDA Determined
Cause 2		 Process control
Action Avid Medical began shipping this product on 05/23/2017. Immediately examine your inventory and quarantine all product subject to this correction. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Correction notice. Please complete the attached Correction Response Form as soon as possible. Attached is a label template for use in the generation of an appropriate warning label for application on all AV10654-10 inventory of impacted lot 1235229. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user location information request to sharon.moll@owens-minor.com. Replacement component swab stick collection systems are available upon request. This correction will be executed with oversight of the associated account sales rep. Please complete and return the enclosed response form as soon as possible.
Quantity in Commerce 330
Distribution Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.
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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