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Fresenius Medical Care Holdings, Inc. recalls The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/discon
Recalled July 28, 2021 · FDA recall Z-2089-2021 · Fresenius Medical Care Holdings
Hazard
Exposed to freezing temperatures due to refrigerated truck malfunctions · FDA Class II
Units
5 cases
Sold at
US Distribution to: TX only
Description
Exposed to freezing temperatures due to refrigerated truck malfunctions
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.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →