FDA Enforcement
Class II
Terminated
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
Recall: Z-2090-2021
·
Reported July 28, 2021
Enforcement
- Recall Number
- Z-2090-2021
- Event ID
- 87998
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- July 28, 2021
- Initiation Date
- April 28, 2021
- Classification Date
- July 16, 2021
- Termination Date
- August 8, 2022
- Address
- 920 Winter St Bld 950, N/A, Waltham, MA, 02451-1521, United States
Description
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
Code Info
Lot Number: B1ZH191, B1ZI092
Distribution
US Distribution to: TX only
Quantity
39 cases