The Recall Desk
ModerateFDA (Devices)·Z-0435-2014·Announced 2013-12-11

CareFusion Recalls VersaSafe Extension Sets Due to Adhesive Defect

CareFusion is recalling VersaSafe Extension Sets because excessive adhesive may prevent the male spin collar from operating as intended.

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, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

CareFusion 303, Inc. is recalling the VersaSafe Extension Intravascular Administration Set, Model No. 21000M-007. The recall involves 3,500 units from Lot No. 13066550 that were distributed nationwide.

The product is being recalled because it may have excessive adhesive, which will prevent the male spin collar from operating as intended. This defect could impact the functionality of the medical device.

Healthcare facilities and consumers should stop using the affected units and contact CareFusion for further instructions or a replacement.

The recalled product

Product
VersaSafe Extension Set, Model No. 21000M-007
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
Affected units
3,500

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)

  • Lot No. 13066550

Distribution

Distributed nationwide across the United States.

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