Device 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
Z-2090-2021
Product summary
- Event
- Event 87998
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 cases
- Official record key
device-enforcement:Z-2090-2021
Official wording
Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions
Code information: Lot Number: B1ZH191, B1ZI092
Distribution pattern: US Distribution to: TX only
Derived failure modes
-
Unknown
Exposed to freezing temperatures due to refrigerated truck malfunctions