Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2083-2021)
See the recall detail below. You can also see other recalls from the same firm in 2021.
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.
Class II
Exposed to freezing temperatures due to refrigerated truck malfunctions
Lot Number: 20NR08163 UDI: (01)00840861102037
US Distribution to: TX only
Voluntary: Firm initiated
