Z-2089-2021 Class II Terminated
FDA device recall Z-2089-2021 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: 5 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
- 5 cases
Product Description
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.
Reason for Recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Distribution Pattern
US Distribution to: TX only
Code Information
Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811