Food, drugs, devices › Smiths Medical ASD Inc.
Device recall: smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear
FDA enforcement event 80635 is a device recall by Smiths Medical ASD Inc. of Minneapolis, MN, initiated 6 Jul 2018 and classified Class III, with 5 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 30 Apr 2019. Initiation: voluntary: firm initiated. Smiths Medical ASD Inc. has 108 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Smiths Medical ASD Inc., Minneapolis, MN.
Reason for recall
""Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0071-2019 | 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. | 12,000 devices | Class III | Terminated | 10 Oct 2018 |
| Z-0072-2019 | smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients. | 2,550 devices | Class III | Terminated | 10 Oct 2018 |
| Z-0073-2019 | smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients. | 3,000 devices | Class III | Terminated | 10 Oct 2018 |
| Z-0074-2019 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients. | 13,750 devices | Class III | Terminated | 10 Oct 2018 |
| Z-0075-2019 | 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. | 850 devices | Class III | Terminated | 10 Oct 2018 |
Context
Other enforcement events for Smiths Medical ASD Inc.
All 108 events for Smiths Medical ASD Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: ""Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.