Recall Z-1059-2023— Owens & Minor Distribution, Inc.

Name: FDA recall Z-1059-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-03

Class III · Ongoing

Class III FDA medical device recall by Owens & Minor Distribution, Inc., initiated 2023-01-03. It names one FDA 510(k) clearance: K131879. Product: FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147. Reason: Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops..

Recalling firm: Owens & Minor Distribution, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2023-01-03
Firm location: Mechanicsville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K131879 — KC 300 SURGICAL MASKKimberly-Clark Corp.·cleared 2013-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

Reason for recall

Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

Data sourced from openFDA. This site is unofficial and independent of the FDA.