Medline Industries, Inc.
Ensemble Arthroscopie DE Genou
1manufacturer
2,043catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Weifang Dragonfly Electronic Technology Co., Ltd. | Weifang | Shandong | Manufacturer | 9 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OII |
| Device type | Arthrogram Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Premarket notification | Exempt |
| Record published | 2018-08-28 |
| Record revised | 2022-06-17 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 3, case of 4, case of 2, pack of 2, case of 6, pack of 3 |
| UDI direct marking | Exempt |
Catalogue Numbers
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| DYNJ55257B | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 596 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 24 |
| Medline | Medline Industries, Inc. | 6 |
| Arthrogram Tray | Carefusion 2200, Inc. | 2 |
| Busse Hosptial Disposables | Robert Busse & Co., Inc. | 1 |
| ACS | American Contract Systems, Inc. | 1 |
| Safe-T | Carefusion 2200, Inc. | 1 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class II | Component change control | Unapproved design changes to the products outside of the 510(k) clearance. | 270,311 total | |
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-25 | Class II | No Marketing Application | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | 27 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 175 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 175 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 222 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-11 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. | 186 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 180 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 1,419 cases (4,349 units) | |
| Medline Industries, LP – Northfield | UDI-DI | 2021-07-01 | Class II | Employee error | The kits may contain an expired component. | 286 total kits for all products | 2023-03-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.