Vygon Recalls 4Fr CT Midline Catheter Trays Due to Sizing Error
Vygon MFG, Inc. is recalling 75 units of 4Fr x 20cm Single Lumen CT Midline Basic Trays because a 3Fr catheter may have been packaged instead of the correct 4Fr size.
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 classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Vygon MFG, Inc., doing business as Churchill Medical Systems, Inc., is recalling 75 units of the 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code VYML4S1001. The recall is due to a potential packaging error where a 3Fr size catheter may have been placed in the tray instead of the specified 4Fr catheter.
The affected product is identified by Lot Number 17B012D and an expiration date of October 31, 2021. The source text indicates that the distribution was limited to one customer located in Tennessee.
The FDA has classified this recall as Class II. The source text does not report any illnesses or injuries associated with this defect. Users should verify the catheter size within the tray against the product specifications before use.
The recalled product
- Product
- 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
- Category
- Medical Device — Catheters
- Affected units
- 75
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)
- Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
Distribution
Distributed in 1 state:
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