medical Class II Updated 2021-07-28

Fresenius Medical Care Holdings, Inc. recalls The MTS Set is a single-use, sterile (EO), non-pyrogenic, op

Recalled Product

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.


Hazard / Issue

Exposed to freezing temperatures due to refrigerated truck malfunctions

Issued by

FDA

Affected States: TX
Lot/Code Info: Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811
View official government recall

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