Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.
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 defect that poses a risk of harm to patients by compromising the closed suction system, 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, Inc. is recalling KimVent Closed Suction Systems for Adults, specifically the 12 F and 14 F Elbow models (Product Codes 216, 221, and 22113). These devices are tracheobronchial suction catheters attached to an airway circuit to aspirate liquids or semisolids from a patient's upper airway.
The recall is due to a defect where the thumb valve may remain partially open after suctioning is completed, even though the valve appears to be closed or in the "LOCKED" position. This issue could compromise the closed nature of the suction system.
The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to Canada. Healthcare providers and facilities should stop using the affected units and contact Halyard Health for instructions on return or replacement.
The recalled product
- Product
- KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 22113) A tracheobronchial suction c
- Manufacturer
- Halyard Health, Inc
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 (6)
- Product Code 216 - M5098T617
- Product Code 221 - M5079T607
- M5082T637
- M5166T631
- Product Code 22113 - M5089T610
- M5166T622
Distribution
Part of a larger recall action
This product is one of 32 recalled by Halyard Health, Inc 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.
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