openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
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.
These labels are deterministic app interpretations, not FDA categories.
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