Class 2 Device Recall Precision Sampling Set

• Date Initiated by Firm: April 21, 2025
• Date Posted: July 29, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2198-2025
• Recall Event ID: 97184
• 510(K)Number: K151107
• Product Classification: Analyzer, gas, carbon-monoxide, gaseous-phase - Product Code CCJ
• Product: Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
• Code Information: Monitor UDI-DI: 00858481006017. Lot (C20206): 231220
• Recalling Firm/ Manufacturer: Capnia Inc; 1101 Chess Dr; Foster City CA 94404-1102
• For Additional Information Contact: Bob Jeney; 904-588-2986
• Manufacturer Reason for Recall: Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
• FDA Determined Cause: Device Design
• Action: Starting on 4/21/2025 Product Advisory and Voluntary Field Action emails were sent to customers who were told affected devices would be replaced. Customers with questions could contact the firm at 904-588-2986
• Quantity in Commerce: 2160
• Distribution: US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CCJ