Vygon IV Start Convenience Kits Recalled for Iodine Stability Issues
Vygon MFG, Inc. is recalling IV Start Convenience Kits because the iodine prep pads failed stability testing for their expiration date.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a stability/efficacy issue regarding the expiration date of the antiseptic pads, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/stability errors without reported harm.
Plain-English summary
Vygon MFG, Inc., doing business as Churchill Medical Systems, Inc., is recalling 21,350 units of Vygon IV Start Convenience Kits. The affected product codes are AMS-623T and AMS-626TGSLF. These kits are used when administering intravenous (IV) lines during emergency situations.
The recall was initiated because the iodine prep pads included in these kits had stability samples that did not meet iodine assay level requirements. Specifically, the samples failed to support the stated 36-month expiration date. All kits containing the affected pads are included in this recall.
The products were distributed in the United States. Users should stop using the affected kits and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
- Category
- Medical Device — IV Supplies
- Affected units
- 21,350
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 (18)
- AMS-623T-6 (1506075D
- 1508057D
- 1511030D
- 1604024D
- 1605080D
- 1610017D
- 1706097D
- 1707055D) and AMS-626TGSLF (1601102D
- 1603099D
- 160581D
- 1607019D
- 1610057D
- 1703068D
- 1703069D
- 1704065d
- 1706076D
- 1707031d
- 1707056D)
Distribution
Distribution scope not specified by the agency.
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