Recall Z-1404-2025 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Smiths Medical ASD, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
| Date | Mar 20, 2025 (initiated Feb 14, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| 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. |
| Quantity | 175,994 US; 45,223 OUS |
| Distribution | US Nationwide distribution. International distribution pending. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871133 | BIOCHEM 8090 CAPNOGRAPH Biochem International, Inc., Apr 21, 1987 |