Recall Z-2089-2021— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2089-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-28

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2021-04-28, terminated 2022-08-08. It names one FDA 510(k) clearance: K173651. 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: Exposed to freezing temperatures due to refrigerated truck malfunctions.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-28
Terminated: 2022-08-08
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC·cleared 2018-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.