Home › Device types › OFA
Cardiovascular Surgical Instruments Tray
FDA product code OFA · Class 1 · Cardiovascular
50
Registered devices
2
Adverse events
21
Recalls
0
510(k) clearances
Devices with this code
CARDINAL HEALTH — Cardinal Health 200, LLCV. Mueller — STERIS CORPORATIONV. Mueller — STERIS CORPORATIONMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.CARDINAL HEALTH — Cardinal Health 200, LLCDeRoyal — DEROYAL INDUSTRIES, INC.V. Mueller — STERIS CORPORATIONCustom Healthcare Systems Inc. — Manus Medical, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.V. Mueller — STERIS CORPORATIONCustom Healthcare Systems Inc. — Manus Medical, LLCV. Mueller — STERIS CORPORATIONMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.On-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.PILLING — TELEFLEX INCORPORATEDV. Mueller — STERIS CORPORATIONV. Mueller — STERIS CORPORATIONOn-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC.V. Mueller — STERIS CORPORATIONMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.V. Mueller — STERIS CORPORATIONCARDINAL HEALTH — Cardinal Health 200, LLCMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-01-07 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2014-10-23 | Centurion Medical Products Corporation | According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira ident |
| 2014-10-23 | Centurion Medical Products Corporation | According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira ident |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing |
| 2014-10-08 | Customed, Inc | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inade |
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