The Fresenius APD Luer-Lock Adapter — Class II medical device recall Z-2088-2021
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-2088-2021 |
|---|---|
| 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 | 20LR08111 |
| Model numbers | 050-95018 |
Product
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).
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-2088-2021. 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.