The MTS Set is a single-use — Class II medical device recall Z-2089-2021
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2021-07-28, distributed in TX. Exposed to freezing temperatures due to refrigerated truck malfunctions
| Recall number | Z-2089-2021 |
|---|---|
| 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 | 2021-04-28 |
| Classified | 2021-07-16 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2022-08-08 |
| Distributed | TX |
| Quantity | 5 cases |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00840861100811 |
| Lot numbers | 20SR08069 |
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 for recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
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-2089-2021. 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.