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Recall Observatory FDA recall evidence

Device 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.

Z-2083-2021

April 28, 2021

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 87998
Status
Terminated
Classification
Class II
Quantity
10 cases
Official record key
device-enforcement:Z-2083-2021

Official wording

Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions

Code information: Lot Number: 20NR08163 UDI: (01)00840861102037

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