Z-1059-2023 Class III Ongoing
FDA device recall Z-1059-2023 was initiated by Owens & Minor Distribution, Inc. on Jan 3, 2023 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 73 cases.
Recall details
- Product Type
- Devices
- Report Date
- Feb 15, 2023
- Initiation Date
- Jan 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 cases
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.
Distribution pattern
US distribution to IL, NC, NY, OH, and PA.
Code information
UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1059-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026