The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0073-2019·Announced 2018-10-10

Smiths Medical Portex Nasal Cannula Recalled for Labeling Error

Smiths Medical ASD Inc. is recalling 3,000 Portex First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expires before it was manufactured.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error involving transposed dates, which fits the criteria for a Low severity score.

Plain-English summary

Smiths Medical ASD Inc. is recalling 3,000 units of the Portex First Breath Adult Nasal Cannula, REF 001289. The affected devices are the Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style, used for the administration of nasal oxygen and humidity to patients.

The recall was initiated because the 'Manufactured' and 'Use By' labels on the devices are transposed incorrectly. This labeling error suggests that the product expires before it was manufactured. The affected lot numbers are 1703171A and 1705152A.

The devices were distributed worldwide, including nationwide in the United States in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. Distribution also included government channels and foreign distribution to Poland and Russia. There was no military distribution. Consumers and healthcare facilities should stop using the affected devices and contact Smiths Medical ASD Inc. for further instructions.

The recalled product

Product
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.
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Respiratory
Hazard
Affected units
3,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot numbers 1703171A and 1705152A

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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