Owens & Minor Distribution, Inc.
Mechanicsville, VA, US
Owens & Minor Distribution, Inc. appears in FDA device records in Mechanicsville, VA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 9 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 9
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1059-2023 | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147 | 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. | Class III | Open, Classified | |
| Z-0343-2023 | Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 | Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection | Class II | Open, Classified | |
| Z-0888-2017 | Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck. | Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc. Owens & Minor first learned of the product issue that prompted the product removal action via customer complaints received in September 2016. Two customer complaints received on September 1"1, 2016 reported surface contamination on the arm slings. Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue. Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions. A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016. The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots. Owens & Minor has quarantined the affected product lots. The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time. Based on the frequency of the product defect as well as evaluation of potential adverse health event risk, Owens & Minor initiated a voluntary recall for the above stated affected product lots. | Class II | Terminated | |
| Z-0735-2016 | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use. | MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. | Class II | Terminated | |
| Z-0734-2016 | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use. | MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. | Class II | Terminated | |
| Z-0733-2016 | MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use. | MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. | Class II | Terminated | |
| Z-0416-2015 | MediChoice Dual-Release Folding Walker with 5" wheel | Product wheels may be too loose, too tight, or fall off. | Class II | Terminated | |
| Z-1192-2013 | MediChoice Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient. | Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use. | Class II | Terminated | |
| Z-0251-04 | PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged*** | Counterfeit product is an unapproved medical device with associated potential health hazard. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain