Class II — Fresenius Medical Care Holdings, Inc.
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Blood chamber connection leaks during the use of the CRIT-LINE® Blood Chamber |
| Product | CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021 |
| Quantity | 22,640,288 |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain. |
| Initiated | 2015-04-27 |
| Classified | 2015-06-05 |
| Terminated | 2021-02-18 |
| Recall number | Z-1716-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Fresenius Medical Care Holdings, Inc. (Z-1716-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71093/
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