GuardIVa Antimicrobial Hemostatic IV Dressing — Class II medical device recall Z-0493-2015
Terminated recall by Bard Access Systems, reported 2014-12-10, distributed in AR, LA, OK, TX. Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile
| Recall number | Z-0493-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Salt Lake City, UT, United States |
| Recall initiated | 2014-11-03 |
| Classified | 2014-12-01 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-05-12 |
| Distributed | AR, LA, OK, TX |
| Quantity | 2,532 units |
| Reason classes | sterility |
| Lot numbers | ASXHT003 |
| Model numbers | FP-23-AD008 |
| Expiration dates | 2016-02-20 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0493-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.