FDA Device recall Z-2083-2021

The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment

• FDA Device
• Class II
• terminated
• Published 2021-07-28

On 2021-07-28 the FDA classified a Class II recall of The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment by Fresenius Medical Care Holdings, citing exposed to freezing temperatures due to refrigerated truck malfunctions.

Read the official FDA Device notice

Product

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.

Reason

Exposed to freezing temperatures due to refrigerated truck malfunctions

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2083-2021%22

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