Vygon Recalls 19Ga Huber Needle Sets Due to Packaging Sterility Concerns
Vygon is voluntarily recalling 156 units of 19Ga x 1 Huber Needle Sets because packaging adhesive issues may compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is a voluntary precautionary measure for a potential sterility issue caused by packaging defects, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Vygon MFG, Inc., doing business as Churchill Medical Systems, Inc., is conducting a voluntary recall of 156 units of 19Ga x 1 Huber Needle Sets (Product Code: MBS-1910, Lot Number: 1706049D). The recall was initiated after the Tyvek supplier notified Vygon of issues with their product, specifically that the Tyvek 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 affected units were distributed in the U.S. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- 19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
- Affected units
- 156
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: 1706049D
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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