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Recall Observatory FDA recall evidence

Device 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.

Z-2089-2021

April 28, 2021

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 87998
Status
Terminated
Classification
Class II
Quantity
5 cases
Official record key
device-enforcement:Z-2089-2021

Official wording

Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions

Code information: Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)00840861100811

Distribution pattern: US Distribution to: TX only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Exposed to freezing temperatures due to refrigerated truck malfunctions