Owens & Minor Distribution, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 28
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1059-2023 | Class III | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround V | January 3, 2023 |
| Z-0343-2023 | Class II | Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 | October 31, 2022 |
| Z-0888-2017 | Class II | Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch | October 31, 2016 |
| Z-0735-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per cas | November 17, 2015 |
| Z-0733-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per cas | November 17, 2015 |
| Z-0734-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per cas | November 17, 2015 |
| Z-0416-2015 | Class II | MediChoice Dual-Release Folding Walker with 5" wheel | June 25, 2014 |
| Z-1192-2013 | Class II | MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 | March 26, 2013 |