The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during
Summary
The FDA issued a Class II for The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage syst by Fresenius Medical Care Holdings, Inc.. Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions.
Details
Source
Device Recall
External ID
Z-2083-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Lot Number: 20NR08163 UDI: (01)00840861102037
Quantity Affected: 10 cases
Reason for Recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Distribution
US Distribution to: TX only
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-28
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Medical Care Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Holdings, Inc. have FDA actions?
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2083-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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