Recall Z-2090-2021— Fresenius Medical Care Holdings, Inc.
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2021-04-28, terminated 2022-08-08. It names one FDA 510(k) clearance: K083542. Product: 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. Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-28
- Terminated
- 2022-08-08
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Data sourced from openFDA. This site is unofficial and independent of the FDA.