CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
FDA device recall Z-1404-2025 · posted 2025-03-20 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- CCK
- Quantity affected
- 175,994 US; 45,223 OUS
- Distribution
- US Nationwide distribution. International distribution pending.
- Date initiated
- 2025-02-14
- Date posted
- 2025-03-20
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOCHEM 8090 CAPNOGRAPH (K871133) | Biochem International, Inc. | 1987-04-21 |