Stay Safe Cap Labeling Recall for Additional Safety Warnings
Fresenius Medical Care is updating the Stay Safe Cap's labeling to include additional warnings and contraindications for potential side effects. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with labeling updates required for contraindications and warnings. No reported illnesses or injuries, but the addition of contraindications indicates specific risk scenarios where the product should not be used.
Plain-English summary
The Stay Safe Cap, manufactured by Fresenius Medical Care Holdings, Inc., is being recalled to add warnings and contraindications to its labeling related to potential side effects. The device is distributed nationwide, affecting 18,236,160 units across all lots (Model No. 050-95012).
No illnesses or injuries have been reported to the Food and Drug Administration. The labeling update is a precautionary measure to ensure patients and healthcare providers have complete information about potential risks and conditions under which the device should not be used.
Consumers and healthcare facilities should review updated labeling materials provided by the manufacturer to understand any new warnings or contraindications before or during use of the Stay Safe Cap.
The recalled product
- Product
- Stay Safe Cap
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device
- Hazard
- inadequate-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 050-95012
- UDI-DI: 00840861100835
- All Lots.
Distribution
Distributed nationwide across the United States.
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