FDA recall Z-2089-2021

Fresenius Medical Care Holdings, Inc. · Class II · 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.

Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

Distribution

US Distribution to: TX only

Key facts

Status
Terminated
Initiation date
2021-04-28
Report date
2021-07-28
Termination date
2022-08-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2089-2021