Recall Z-0075-2019 ยท CAT Cannula, Nasal, Oxygen
Smiths Medical ASD Inc.
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
| Date | Jul 6, 2018 |
| Status | Terminated |
| Reason | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. |
| Root cause | Labeling design |
| Action | The recalling firm issued an Urgent Medical Device Recall letters dated July 6, 2018 via UPS tracked hard-copy mailing The letter identified the affected product, problem and actions to be taken. Customers were requested to return affected products using the enclosed shipping label. For questions email Stericycle at SmithsMedical7434@stericycle.com. |
| Quantity | 850 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.