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Radiology-Diagnostic Kit
FDA product code OIP · Class 2 · Radiology
1,163
Registered devices
4
Adverse events
5
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, LLCCARDINAL HEALTH — Cardinal Health 200, LLCSheathes — SHEATHING TECHNOLOGIES, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCSheathes3D — SHEATHING TECHNOLOGIES, INC.Sheathes — SHEATHING TECHNOLOGIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCSheathes — SHEATHING TECHNOLOGIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCSheathes3D — SHEATHING TECHNOLOGIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-04 | American Contract Systems Inc. | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. The |
| 2023-08-16 | Cardinal Health 200, LLC | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2022-03-22 | American Contract Systems, Inc. | Product was sterilized with a higher than specification EO concentration. |
| 2021-08-10 | ROi CPS LLC | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. |
| 2021-08-10 | ROi CPS LLC | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. |
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