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Burn Kit Without Drug
FDA product code OJJ · Class 1 · General, Plastic Surgery
715
Registered devices
3
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster |
| 2024-10-09 | MEDLINE INDUSTRIES, LP - Northfield | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2023-09-11 | ROi CPS LLC | Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-u |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2017-06-26 | Certified Safety Mfg Inc | Burn Sheet has possibility of being shredded. |
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