FDAFDA · Food and drugs·Recall number Z-0493-2015
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Published December 10, 2014 · Recall initiated: November 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Access Systems
- Distributor
- US Distribution to state of: TX, OK, LA, and AR.
- Lot
- Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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