Smiths Medical ASD, Inc.: CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution. International distribution pending. Quantity: 175,994 US; 45,223 OUS Lot/code info: UDI-DI 30610586038444 Lots WW8214 022980-1-22 022404-1-17 021860-1-10 021110-1-7 020609-1-2 016288-1-1 022980-1-24 022404-1-18 021860-1-14 021110-1-8 020609-1-3 017774-1-1 022980-1-23 022404-1-19 021860-1-13 021110-1-9 020609-1-4 018139-1-1 022980-1-26 022404-1-20 021860-1-15 021110-1-10 020609-1-5 018184-1-1 022980-1-27 022404-1-21 021860-1-17 021110-1-11 020609-1-6 018252-1-1 022980-1-28 022404-1-22 021860-1-16 021110-1-12 020609-1-7 018458-1-1 022980-1-25 022404-1-23 021860-1-18 021110-1-13 020609-1-8 018457-1-1 022980-1-32 022404-1-24 021860-1-20 021110-1-14 020609-1-9 018614-1-1 022980-1-30 022404-1-25 021860-1-21 021110-1-16 020609-1-10 018641-1-1 022980-1-29 022404-1-26 021860-1-19 021110-1-15 020609-1-11 018789-1-1 022980-1-31 022404-2-2 021860-2-1 021110-1-17 020609-1-12 018789-2-1 022980-1-33 022404-1-27 021860-2-2 021110-1-18 020609-1-13 018789-3-1 023592-1-3 022404-2-1 021860-1-22 021110-1-19 020609-1-14 018789-4-1 023592-1-2 022404-2-3 021860-2-5 021110-1-20 020609-1-15 018936-1-1 023592-1-1 022404-2-4 021860-2-3 021110-1-21 020609-1-16 018936-2-1 023592-1-5 022404-2-5 021860-2-4 021110-1-22 020609-1-19 018936-3-1 023592-1-6 022404-2-6 021860-2-6 021110-1-23 020609-1-20 018936-4-1 023592-1-4 022404-2-7 021860-2-8 021110-1-24 020609-1-17 019179-1-1 023592-1-7 022404-2-8 021860-2-7 021110-1-25 020609-1-21 019254-1-1 023592-1-9 022404-2-9 021860-2-10 021110-1-26 020609-1-18 019323-1-1 023592-1-8 022404-2-10 021860-2-11 021110-1-27 020609-1-23 019383-1-1 023592-1-12

UPC codes

30610586038444

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.