Drug recall
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO…
FDA recall event 70574 · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 70574 |
|---|---|
| Recall numbers | Z-1549-2015, Z-1550-2015, Z-1551-2015, Z-1552-2015 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | 2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2…, 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS…, 2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and…, 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen. |
| Initiation date | Feb 20, 2015 |
| Report date | May 6, 2015 |
| Termination date | May 18, 2021 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: