The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0787-2017·Announced 2016-12-28

FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling

Vygon MFG, Inc. is recalling 31,500 AMS-651 Microbore extension sets because the package displays an incorrect priming volume.

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, which typically indicates a risk of temporary or medically reversible health consequences. The specific hazard is a labeling error regarding the priming volume, which fits the criteria for moderate severity involving minor labeling errors or low-risk issues.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for the AMS-651, 120" Microbore extension set with slide clamp. The recall was initiated by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., because the device package contains an incorrect priming volume. These accessory devices are used to administer medical fluids.

A total of 31,500 units were distributed in California. The affected lots are identified by the following codes: 1601064D, 1603065D, 1605009D, 1606038D, 1607016D, 1607072D, 1608067D, and 1609069D.

Healthcare providers 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-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Manufacturer
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Category
Medical Device — Infusion Accessories
Hazard
Affected units
31,500

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)

  • 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D

Distribution

Distributed in 1 state:

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