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Recall Observatory FDA recall evidence

Device product

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

Z-0493-2015

November 03, 2014

Class II

Product summary

Firm
Bard Access Systems
Event
Event 69683
Status
Terminated
Classification
Class II
Quantity
2532 units
Official record key
device-enforcement:Z-0493-2015

Official wording

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.

Code information: Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.