Recall record at a glance
| Official record | Z-1278-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Report date | Apr 11, 2018 |
| Recall initiation date | Dec 14, 2017 |
| Quantity | 127 |
| Location | Waltham, MA, United States |
Official product description
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.
Why the product 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.
Distribution information
US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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