Recall Z-2090-2021 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Fresenius Medical Care Holdings, Inc.
050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
| 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 | 39 cases |
| Distribution | US Distribution to: TX only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083542 | FRESENIUS STERILE STAY SAFE CAP Fresenius Medical Care North America, Dec 29, 2008 |