FDA Medical Device Recalls (openFDA)
Bard Access Systems: GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
- Recall number
- Z-0493-2015
- Recalling firm
- Bard Access Systems
- Product
- GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
- Status
- Terminated
- Initiated
- 2014-11-03
- Posted
- 2014-12-01
- Terminated
- 2015-05-12
- 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.
- 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
- 2532 units
- Distribution
- US Distribution to state of: TX, OK, LA, and AR.
- Lot, serial or model codes
- Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28