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Open, Classified

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

FDA Recall Z-1405-2025 · Posted 2025-03-20

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusOpen, Classified
Product CodeCCK
Date Initiated2025-02-14
Product Quantity175,994 US; 45,223 OUS

Reason for Recall

Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

Firm Action

On February 14, 2025, customers were notified via Urgent Medical Device Correction letters. Consignees were instructed to locate and quarantine all affected product within their institution and destroy them. The recalling firm will contact customers who have returned completed response forms identifying affected products within their possession to discuss credit.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution. International distribution pending.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941982CAPNOCHECKBci, Inc. · 1994-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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