FDA Device recall Z-2089-2021
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used…
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used… by Fresenius Medical Care Holdings, citing exposed to freezing temperatures due to refrigerated truck malfunctions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2089-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-28 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | TX |
Product
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.
Reason
Exposed to freezing temperatures due to refrigerated truck malfunctions
Identifiers
| code_info | Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2089-2021%22
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