050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use… — Class II medical device recall Z-2090-2021
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-2090-2021 |
|---|---|
| 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 | 39 cases |
| Reason classes | device malfunction |
| Lot numbers | B1ZH191, B1ZI092 |
Product
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
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-2090-2021. 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.