Vygon Recalls 3-Way Stopcocks Due to Packaging Sterility Concerns
Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks 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 3/5 (High).
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: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Vygon MFG, Inc., dba Churchill Medical Systems, Inc., is conducting a voluntary recall of 200 units of 3-Way Standardbore Stopcocks (Product Code: AMS-100, Lot Number: 1706064D). The recall was initiated after the company's Tyvek supplier reported that the Tyvek material may not be coated completely, which could cause gaps in the adhesive used to seal the product packaging.
The potential lack of adhesive may affect the sterility of the product. The recalled items were distributed in the U.S. This recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare facilities should stop using the affected stopcocks and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 3-Way Standardbore Stopcock. Product Code: AMS-100.
- Affected units
- 200
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: 1706064D
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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