Home › Device types › FJI
Dialyzer, Capillary, Hollow Fiber
FDA product code FJI · Class 2 · Gastroenterology, Urology
44
Registered devices
8,424
Adverse events
7
Recalls
131
510(k) clearances
Devices with this code
Molded Products, Inc. — MOLDED PRODUCTS, INC.POLYFLUX — Gambro Dialysatoren GmbHHemoflow™ — Fresenius Medical Care Holdings, Inc.Diacap® — B.Braun Avitum AGDialysate POrt Caps 1" Bulk — REPROCESSING PRODUCTS CORPORATIONMolded Products, Inc. — MOLDED PRODUCTS, INC.Diacap® — B.Braun Avitum AGBlood Port Caps Twist Lock ISO Bulk — REPROCESSING PRODUCTS CORPORATIONPOLYFLUX — Gambro Dialysatoren GmbHDiacap® — B.Braun Avitum AGDialysate Port Caps 1.5" Bulk — REPROCESSING PRODUCTS CORPORATIONPolyflux — Gambro Dialysatoren GmbHDialysate Port Cap - E-Z Grip® Twist Lock - Rigid — REPROCESSING PRODUCTS CORPORATIONPOLYFLUX — Gambro Dialysatoren GmbHBlood Port Caps Bulk — REPROCESSING PRODUCTS CORPORATIONDiacap® — B.Braun Avitum AGBlood Port Caps Twist Lock ISO — REPROCESSING PRODUCTS CORPORATIONPOLYFLUX — Gambro Dialysatoren GmbHMolded Products, Inc. — MOLDED PRODUCTS, INC.Diacap® — B.Braun Avitum AGDiacap® — B.Braun Avitum AGDiacap® — B.Braun Avitum AGBlood Port Caps — REPROCESSING PRODUCTS CORPORATIONHemoflow™ — Fresenius Medical Care Holdings, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-29 | Fresenius Medical Care Holdings, Inc. | To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version w |
| 2016-02-26 | Fresenius Medical Care Renal Therapies Group, LLC | Dialyzer header leak due to possible improper torque |
| 2006-10-12 | Asahi Medical Co., Ltd | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damagi |
| 2003-12-30 | Toray Marketing & Sales (America), Inc | Potential loose header (end cap) on hollow fiber dialyzers. |
| 2003-12-30 | Toray Marketing & Sales (America), Inc | Potential loose header (end cap) on hollow fiber dialyzers. |
| 2003-12-30 | Toray Marketing & Sales (America), Inc | Potential loose header (end cap) on hollow fiber dialyzers. |
| 2003-12-30 | Toray Marketing & Sales (America), Inc | Potential loose header (end cap) on hollow fiber dialyzers. |
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