Recall Z-0493-2015
Bard Access Systems · initiated November 3, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Codes / lots: Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
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: 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.
Details
- Recall number
- Z-0493-2015
- Initiated
- November 3, 2014
- Posted by FDA
- December 1, 2014
- Terminated
- May 12, 2015
- Product code
- FRO – Dressing, Wound, Drug
- Quantity
- 2532 units
- Distribution
- US Distribution to state of: TX, OK, LA, and AR.
- Recalling firm
- Bard Access Systems, Salt Lake City, UT