CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report
Optiflux F160NR Capillary High Flux Dialyzer Single Use recalled
Fresenius Medical Care Renal Therapies Group is recalling Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, distributed nationwide in the US. The recall was initiated on 5 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0658-2019
- FDA event ID
- 81598
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2018
- FDA classified
- 20 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2018 | Recall initiated by company | |
| 20 Dec 2018 | Classified by FDA | +45 days |
| 26 Dec 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for external blood leaks from the dialyzer header
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Potential for external blood leaks from the dialyzer header
Which lots are affected?
Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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