FDA-Device2014-12-10Class II

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

Bard Access Systems
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.

Sold states
US Distribution to state of: TX, OK, LA, and AR.
Affected count
2532 units
Manufactured in
605 North 5600 West, N/A, Salt Lake City, UT, United States
Products
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0493-2015

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