Bard Access Systems: Medical Device Recall in 2014 - (Recall #: Z-0493-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2014.
Data Source: FDA.
Product Description:
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Product Classification:
Class II
Date Initiated: November 3, 2014
Date Posted: December 10, 2014
Recall Number: Z-0493-2015
Event ID: 69683
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.
Status: Terminated
Product Quantity: 2532 units
Code Information:
Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
Distribution Pattern:
US Distribution to state of: TX, OK, LA, and AR.
Voluntary or Mandated:
Voluntary: Firm initiated