Recall Z-0360-2014 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
SALTER LABS
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
| Date | Nov 19, 2013 (initiated Nov 1, 2013) |
| Status | Terminated |
| Reason | It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length. |
| Root cause | Labeling Change Control |
| Action | Salter Labs called the five customers that received product from the three lots, then follow-up immediately by sending a recall notification letter directly to each customer. Each letter will identify all shipments of subject product that they received. All customers letters were sent certified mail, return receipt requested. |
| Quantity | 91 cases (25 units per case) |
| Distribution | Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894350 | SALTER LABS MODEL #4009 SAMPLE LINES Salter Labs, Oct 3, 1989 |