FDAClass IIJuly 28, 2021

The Drain Bag Set recall

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…

Why was The Drain Bag Set recalled?

Exposed to freezing temperatures due to refrigerated truck malfunctions

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 20NR08163 UDI: (01)00840861102037

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…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
10 cases
Distribution
US Distribution to: TX only
Recall date
July 28, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls