FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling
Vygon MFG is recalling 30,700 AMS-636 Microbore extension sets because the package displays an incorrect priming volume.
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 classified as FDA Class II due to a labeling error (incorrect priming volume). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the AMS-636, 60" Microbore extension set. The recall was initiated by Vygon MFG, Inc., doing business as Churchill Medical Systems, Inc., due to a labeling error on the device package. Specifically, the priming volume printed on the packaging is incorrect.
The affected products are accessory devices used to administer medical fluids. A total of 30,700 units were distributed nationwide in the states of New Jersey, Texas, Virginia, Florida, Massachusetts, Illinois, Michigan, New York, Ohio, Washington, Pennsylvania, and West Virginia. The recall covers specific lot codes: 1610092D, 1611091D, 1612068D, and 1612074D.
Healthcare facilities and consumers should check their inventory for these specific lot codes. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
- Hazard
- Affected units
- 30,700
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)
- 1610092D 1611091D 1612068D 1612074D
Distribution
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