Voluntary Recall of Nutrisafe 2 Syringes Due to Packaging Adhesive Issues
Vygon is voluntarily recalling specific lots of Nutrisafe 2 syringes because packaging adhesive gaps may compromise sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a potential sterility issue caused by packaging defects, with no reported illnesses or injuries.
Plain-English summary
Vygon MFG, Inc., dba Churchill Medical Systems, Inc., is conducting a voluntary recall of Nutrisafe 2 35 mL Syringes for Safety Connection (Product Code: 1015.352M). The recall affects Lot Number 1705060D, which was distributed in the United States.
The recall was initiated after the Tyvek supplier notified Vygon of issues with their product. Specifically, the Tyvek material may not be coated completely, causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
- Category
- Medical Device — Syringes
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 (1)
- Lot Number: 1705060D
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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