Recall Z-0493-2015 ยท FRO Dressing, Wound, Drug
Bard Access Systems
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
| Date | Dec 1, 2014 (initiated Nov 3, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Mixed-up of materials/components |
| Action | A customer letter was sent on 11/3/14 requesting immediate examination of inventory and to quarantine the products for return. |
| Quantity | 2532 units |
| Distribution | US Distribution to state of: TX, OK, LA, and AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.