Recalls / —
—#165941
Product
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
- FDA product code
- CAT — Cannula, Nasal, Oxygen
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Lot numbers 1703221A and 1705111A
Why it was recalled
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Root cause (FDA determination)
Labeling design
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2018-07-06
- Terminated
- 2019-04-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.