CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors… — Class II medical device recall Z-1716-2015
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2015-06-17, distributed nationwide. Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
| Recall number | Z-1716-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2015-04-27 |
| Classified | 2015-06-05 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2021-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, EG, ES, GB, IE, MX, NL, NO, SI |
| Quantity | 22,640,288 |
| Reason classes | packaging |
| Model numbers | CL10021021 |
Product
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Reason for recall
Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1716-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.