Recall Z-0605-2012 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
SALTER LABS
ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203
| Date | Jan 11, 2012 (initiated Dec 7, 2011) |
| Status | Terminated |
| Reason | Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors). |
| Root cause | Process control |
| Action | The firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690. |
| Quantity | 240 cases |
| Distribution | Nationwide Distribution -- TX and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892406 | MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA Salter Labs, Jul 24, 1989 |