Vygon Recalls LifeGuard Huber Needles Due to Packaging Sterility Concerns
Vygon is voluntarily recalling 396 units of LifeGuard Huber Needles 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: The recall is a voluntary precautionary measure initiated due to a potential packaging defect that may affect sterility, with no reported illnesses or injuries in the source text.
Plain-English summary
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., is conducting a voluntary recall of 396 units of 20Ga x .75 LifeGuard Huber Needles with Y-site (Product Code: CLGY-2034, Lot Number: 1706017D). 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 specify specific healthcare facilities or end-users, nor does it report any illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using the affected lots immediately and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
- Category
- Medical Device — Needles
- Affected units
- 396
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: 1706017D
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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