Z-1059-2023Class III

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

Name: Z-1059-2023 FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor...
Creator: Owens & Minor Distribution, Inc.
Published: 2023-01-03
License: https://open.fda.gov/license/

Owens & Minor Distribution, Inc. / initiated 2023-01-03 / Open, Classified / root cause: labeling and UDI

FDA source

Owens & Minor Distribution, Inc. began a recall of FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147 on 2023-01-03. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1059-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-01-03
Posted: 2023-02-03
Recalling firm: Owens & Minor Distribution, Inc.
Product: FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Product code: FXX Mask, Surgical
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On January 3, 2023, the firm notified affected distributors via email with a "VOLUNTARY FIELD CORRECTION" letter. Consignees are instructed to immediately stop use of the product, quarantine any stock and destroy all the product using the facility s standard disposal procedure. Consignees are requested to complete and return a Recall FIELD CORRECTION RESPONSE FORM and a Certificate of Destruction. If you have any questions, please email Anu Singh @ [email protected] using the Event # FCA-2022-012 in the header of the response.
Quantity in commerce: 73 cases
Distribution: US distribution to IL, NC, NY, OH, and PA.
Product codes and lots: UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1059-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1059-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-03

Product code FXX

K131879Class IIKc 300 Surgical MaskKimberly-Clark Corp. / cleared 2013-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)