High flux dialyzers recalled to instruct users on newly redesigned press-on caps
Fresenius Medical Care is issuing a recall covering Optiflux High Flux E-beam Dialyzers to tell users that the caps changed from threaded to press-on and must be pressed firmly to affix.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a precautionary instructional update: the record describes added user information after a cap redesign, with no defect or reported harm.
Plain-English summary
Optiflux High Flux E-beam Dialyzers, model numbers 0500316E (F160NRe), 0500318E (F180NRe), 0500320E (F200NRe) and 0500325E (F250NRe), are covered by a recall issued to provide further information to the user to ensure proper use of the device.
The caps had been changed from a threaded version to a press-on version, and the user must press the caps firmly onto the dialyzer to securely affix the cap.
The enforcement record states 172,494,732 units, or 14,374,561 cases at 12 units per case, across all lots manufactured after 6 September 2023. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The record describes an instructional update following a design change rather than a defect, and reports no injuries. Dialysis facilities should follow the updated instructions when fitting caps.
The recalled product
- Product
- Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Dialyzer
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 1. Model: 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM
- UDI-DI: 840861100149
- All Lots manufactured after SEP/06/2023
- 2. Model: 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM
- UDI-DI: 840861100156
- 3. Model: 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM
- UDI-DI: 840861100163
- 4. Model: 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
- UDI-DI: 840861100170
Distribution
Distributed nationwide across the United States.
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