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Terminated

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

FDA Recall Z-0493-2015 · Posted 2014-12-01

Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeFRO
Date Initiated2014-11-03
Date Terminated2015-05-12
Product Quantity2532 units

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.

Firm Action

A customer letter was sent on 11/3/14 requesting immediate examination of inventory and to quarantine the products for return.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US Distribution to state of: TX, OK, LA, and AR.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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