Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment Risk
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that poses a risk of harm to patients during airway management, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes, 7.0 mm, distributed by Kimberly Clark Global Sales, LLC. The product is used for airway management by oral intubation of the trachea and for the removal of secretions that accumulate in the subglottic space.
The recall is being issued because the cuff inflation line may detach from the endotracheal tube during use. This defect could compromise the device's function during airway management.
The recall includes 250 cases (10 tubes per case) with specific lot numbers listed in the agency record. The products were distributed nationwide in the United States and internationally to Australia, Canada, Europe, Hong Kong, New Zealand, and the United Arab Emirates. Healthcare facilities and users should stop using the affected lots and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
- Manufacturer
- Halyard Health
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 (20)
- Product Code: 13220
- Lot numbers: AA3213
- AA3227
- AA3227V01
- AA3245
- AA3245V02
- AA3253V02
- AA3269V01
- AA3274V01
- AA4038
- AA4038V03
- AA4038V04
- AA4038V06
- AA4062
- AA4062V01
- AA4104V02
- AA4111V01
- AA4113V01
- AA4134V01 & AA4146V01
- AA4146V04
Distribution
Part of a larger recall action
This product is one of 5 recalled by Halyard Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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FDA (Devices) · 2016-12-21
- HighHalyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect
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- HighHalyard Health Recalls KimVent Closed Suction Systems Due to Defects
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- HighHalyard Health Recalls KimVent Wet Pak Closed Suction Systems
FDA (Devices) · 2015-03-11
- HighHalyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
FDA (Devices) · 2014-12-31
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