FDA Device recall Z-1716-2015
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021 by Fresenius Medical Care Holdings, citing blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1716-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-27 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Reason
Blood chamber connection leaks during the use of the CRIT-LINE¿ Blood Chamber
Identifiers
| code_info | All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1716-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.