Z-0493-2015Class II

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

Name: Z-0493-2015 GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA...
Creator: Bard Access Systems
Published: 2014-11-03
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2014-11-03 / Terminated / root cause: sterility

FDA source

Bard Access Systems began a recall of GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006 on 2014-11-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0493-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-03
Posted: 2014-12-01
Terminated: 2015-05-12
Recalling firm: Bard Access Systems, Inc.
Product: GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Product code: FRO Dressing, Wound, Drug
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.
Root cause tag: sterility
FDA root cause: 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.
Product codes and lots: Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0493-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0493-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-01

Product code FRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)