Vygon Recalls Pediatric CVC Trays Due to Packaging Adhesive Defect
Vygon is voluntarily recalling 300 units of CVC Tray Pediatrics because packaging adhesive gaps may compromise 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: 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 300 units of CVC Tray Pediatrics (Product Code: AMS-9335CP-2, Lot Number: 1706044D). 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.
The potential lack of adhesive may affect the sterility of the product. The affected units were distributed in the U.S. No illnesses or injuries have been reported in the source text.
Healthcare providers and consumers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
- Affected units
- 300
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: 1706044D
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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