Home › Device types › OKE
Port Introducer Kit
FDA product code OKE · Class 2 · General Hospital
1,809
Registered devices
6
Adverse events
10
Recalls
0
510(k) clearances
Devices with this code
CARDINAL HEALTH — Cardinal Health 200, LLCVYGON — Vygon CorporationACS — AMERICAN CONTRACT SYSTEMS, INC.Regard™ — ROI CPS, 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, LLCACS — AMERICAN CONTRACT SYSTEMS, 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, 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, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCACS — AMERICAN CONTRACT SYSTEMS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HC |
| 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 |
| 2025-02-06 | American Contract Systems Inc | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| 2023-11-29 | American Contract Systems, Inc. | During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There i |
| 2023-08-16 | Cardinal Health 200, LLC | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2022-06-16 | American Contract Systems, Inc. | Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
| 2008-04-08 | Tri-State Hospital Supply Corporation | The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination. |
| 2008-04-08 | Tri-State Hospital Supply Corporation | The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination. |
| 2008-04-08 | Tri-State Hospital Supply Corporation | The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination. |
| 2008-04-08 | Tri-State Hospital Supply Corporation | The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination. |
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