FDA Device recall Z-2090-2021
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…
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of 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… 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-2090-2021 |
| 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
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
Exposed to freezing temperatures due to refrigerated truck malfunctions
Identifiers
| code_info | Lot Number: B1ZH191, B1ZI092 |
|---|
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-2090-2021%22
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