Recall Z-2089-2021 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Fresenius Medical Care Holdings, Inc.
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proxi
| 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 | 5 cases |
| Distribution | US Distribution to: TX only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set Fresenius Medical Care Renal Therapies Group, LLC, Feb 14, 2018 |