Z-2090-2021 Class II Terminated
FDA device recall Z-2090-2021 was initiated by Fresenius Medical Care Holdings, Inc. on April 28, 2021 and is designated Class II. Reason for recall: Exposed to freezing temperatures due to refrigerated truck malfunctions The recall status is terminated (terminated August 8, 2022). Affected quantity: 39 cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- April 28, 2021
- Termination Date
- August 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 cases
Product 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 for Recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Distribution Pattern
US Distribution to: TX only
Code Information
Lot Number: B1ZH191, B1ZI092