GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Cod
FDA device recall Z-0493-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 2532 units
- Distribution
- US Distribution to state of: TX, OK, LA, and AR.
- Date initiated
- 2014-11-03
- Date posted
- 2014-12-01
- Date terminated
- 2015-05-12
- Location
- Salt Lake City, UT
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