Recall Z-2083-2021 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Fresenius Medical Care Holdings, Inc.
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
| Date | Apr 28, 2021 |
| Status | Terminated |
| Reason | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Root cause | Environmental control |
| Action | Fresenius issued telephone script communication on April 28.2021 stating reason for recall, heath risk and action to take: Tell them you already contacted their Home Therapy Nurse to alert them that you would be calling them. o The purpose of my call today is that you received a delivery from us on (either Feb 22nd or Feb 23rd). o The truck you received a delivery from had a temperature malfunction due to the bad storms Texas experienced back in February. This caused the product you were delivered to be exposed to freezing or near freezing temperatures for about 3 hours. o o I see you receive |
| Quantity | 10 cases |
| Distribution | US Distribution to: TX only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173363 | Cycler Drain Bag Set Fresenius Medical Care Renal Therapies Group, LLC, Jan 24, 2018 |