Recall Z-0493-2015— Bard Access Systems

Name: FDA recall Z-0493-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-03

Class II · Terminated

Class II FDA medical device recall by Bard Access Systems, initiated 2014-11-03, terminated 2015-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.. Reason: 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..

Recalling firm: Bard Access Systems
Classification: Class II
Status: Terminated
Initiated: 2014-11-03
Terminated: 2015-05-12
Firm location: Salt Lake City, UT, United States

Product description

GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.