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Polyflux
Gambro Dialysatoren GmbH · Model 21L · UDI-DI 07332414048181
FJI
Prescription
10
510(k) clearances
8,433
Adverse events (157 deaths)
7
Recalls
8
Facilities
Description
The Polyflux 21L is intended for use in haemodialysis for the treatment of chronic or acute renal failure
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 whereby the user must |
| 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 damaging the dialyzer nozz |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.