Food, drugs, devices › Fresenius Medical Care Holdings, Inc.
Device recall: Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
FDA enforcement event 67313 is a device recall by Fresenius Medical Care Holdings, Inc. of Waltham, MA, initiated 4 Feb 2014 and classified Class II, with 9 product records.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 18 May 2021. Initiation: voluntary: firm initiated. Fresenius Medical Care Holdings, Inc. has 66 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fresenius Medical Care Holdings, Inc., Waltham, MA.
Reason for recall
"Dialysate Port Leak During Priming of the Dialyzers"
Distribution
"Worldwide distribution: USA (nationwide) and the country of: Mexico."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1098-2014 | Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment. | 3,460,672 units | Class II | Terminated | 5 Mar 2014 |
| Z-1099-2014 | Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment. | 6720 units | Class II | Terminated | 5 Mar 2014 |
| Z-1100-2014 | Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment. | 3,744,122 | Class II | Terminated | 5 Mar 2014 |
| Z-1101-2014 | Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment. | 52,752 units | Class II | Terminated | 5 Mar 2014 |
| Z-1102-2014 | Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment. | 317,796 units | Class II | Terminated | 5 Mar 2014 |
| Z-1103-2014 | Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment. | 19,596 units | Class II | Terminated | 5 Mar 2014 |
| Z-1104-2014 | Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment. | 5,244 units | Class II | Terminated | 5 Mar 2014 |
| Z-1105-2014 | Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment. | 100,008 units | Class II | Terminated | 5 Mar 2014 |
| Z-1106-2014 | Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment. | 34,752 units | Class II | Terminated | 5 Mar 2014 |
Context
Other enforcement events for Fresenius Medical Care Holdings, Inc.
All 66 events for Fresenius Medical Care Holdings, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Dialysate Port Leak During Priming of the Dialyzers"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: USA (nationwide) and the country of: Mexico."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 May 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.