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Catheter Introducer Kit
FDA product code OFC · Class 2 · Cardiovascular
22
Registered devices
101
Adverse events
4
Recalls
1
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, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCPrytime Medical Devices, Inc. — Prytime Medical Devices, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCPrytime Medical Devices, Inc. — Prytime Medical Devices, Inc.Lingeman Percutaneous Tract Kit — BOSTON SCIENTIFIC CORPORATIONCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCPercutaneous Tract Kit — BOSTON SCIENTIFIC CORPORATIONCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCTorqMax Sheath Grip Accessory — Spectranetics CorporationCARDINAL HEALTH — Cardinal Health 200, LLCLandmark Catheter Introducer Kit — ZIEN MEDICAL TECHNOLOGIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss |
| 2026-03-11 | ARROW INTERNATIONAL, LLC | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2026-03-11 | ARROW INTERNATIONAL, LLC | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2020-12-14 | Prytime Medical Devices, Inc. | There is a potential that a catheter convenience set contains a 21G access needle instead of the correct 18G needle. If the 21G needle is used to gain vascular |
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