GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
This recall has been terminated (originally issued December 1, 2014).
- Company
- Bard Access Systems
- Recall Initiated
- November 3, 2014
- Posted
- December 1, 2014
- Terminated
- May 12, 2015
- Recall Number
- Z-0493-2015
- Quantity
- 2532 units
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
Distribution
US Distribution to state of: TX, OK, LA, and AR.
Lot / Code Info
Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
Root Cause
Mixed-up of materials/components
Action Taken
A customer letter was sent on 11/3/14 requesting immediate examination of inventory and to quarantine the products for return.
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