Mechanicsville, VA, United States
Owens & Minor Distribution, Inc. recalls
2 recalls recorded since 2018, most recently on 3 January 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 3 January 2023
- 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.
- Distribution
- US distribution to IL, NC, NY, OH, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1059-2023
- FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Ongoing Class II Medical devices
- Recall started
- 31 October 2022
- Reason
- Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
- Distribution
- IL, IN, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0343-2023
- Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.