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U.S. Department of Health and Human Services

Class 2 Device Recall GuardIVa Antimicrobial Hemostatic IV Dressing

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  Class 2 Device Recall GuardIVa Antimicrobial Hemostatic IV Dressing see related information
Date Initiated by Firm November 03, 2014
Date Posted December 01, 2014
Recall Status1 Terminated 3 on May 12, 2015
Recall Number Z-0493-2015
Recall Event ID 69683
Product Classification Dressing, wound, drug - Product Code FRO
Product GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Code Information Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact Carlos Arriscorreta
801-522-5706
Manufacturer Reason
for Recall		 Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile unit samples which potentially could be used clinically.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action A customer letter was sent on 11/3/14 requesting immediate examination of inventory and to quarantine the products for return.
Quantity in Commerce 2532 units
Distribution US Distribution to state of: TX, OK, LA, and AR.
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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