Reported Apr 11, 2018 · Terminated
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI…
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- 2008 K2 Hemodialysis Machine with software version 5.40
- Models(1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy
- Lot codes and dates
- Serial Numbers0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Number
234 of 234 codes
1K0S1698981K0S1699541K0S1701541K0S1702341K0S1712751K0S1712861K0S1714211K0S1714362K0S1762432K0S1762442K0S1762572K0S1762642K0S1762712K0S1762732K0S1762782K0S1762802K0S1762812K0S1762832K0S1762862K0S1764432K0S1764722K0S1766334K0S1888344K0S1888414K0S1888434K0S1889874K0S1892464K0S1892934K0S1893004K0S1893534K0S1894884K0S1897974K0S1899154K0S1899394K0S1900644K0S1900674K0S1900914K0S1901114K0S1901154K0S1901194K0S1901214K0S1901264K0S1901404K0S1901414K0S1901454K0S1901464K0S1901664K0S1901734K0S1901754K0S1901834K0S1902034K0S1902124K0S1902224K0S1902264K0S1915754K0S1919105K0S1936815K0S1936825K0S1936885K0S193689
- Serial Numbers0K0S151801 UDI 00840861100866 190630,(+Serial Number) UDI 00840861100859 PLS 190610, (+Serial Number
- Amount recalled
- 127
Where it was sold
Why it was recalled
When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Fresenius Medical Care Renal Therapies Group,… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.