CAPNOCHECK Airway Adapter May Break Off, Risking Ventilation Loss
CAPNOCHECK BCI Airway Adapters may break off when a valve or tube is attached, causing airway circuit disconnection and loss of ventilation. This could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
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 3/5 (High).
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: FDA Class II medical device with potential for serious patient harm (ventilation loss, hypoxia, cardiopulmonary collapse) but no reported injuries or deaths. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the CAPNOCHECK BCI Airway Adapter (Model Number BSR, Product Code WW8214) due to a manufacturing defect. The adapter does not meet specification and may break off when a valve or tube is attached during use.
Device failure may result in inaccurate readings, a break in the airway circuit, and loss of ventilation. A disconnected airway circuit could prevent proper ventilation of a patient, potentially leading to inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
The recall affects approximately 175,994 units distributed nationwide in the United States and 45,223 units distributed internationally. Healthcare facilities using this product should stop use immediately and contact Smiths Medical ASD, Inc. for instructions on returning or replacing affected adapters.
The recalled product
- Product
- CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
- Manufacturer
- Smiths Medical ASD, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD, 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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