The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0075-2019·Announced 2018-10-10

Smiths Medical Portex Nasal Oxygen Cannula Recalled for Labeling Error

Smiths Medical ASD Inc. is recalling 850 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' dates are transposed, incorrectly suggesting the product expired before it was made.

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error rather than a physical defect or contamination.

Plain-English summary

Smiths Medical ASD Inc. is recalling 850 units of the Portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. The recall is due to a labeling error where the 'Manufactured' and 'Use By' labels are transposed, which incorrectly suggests that the product expires before it was manufactured.

The affected devices, identified by Lot number 1705171A, were distributed worldwide. In the United States, distribution occurred nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. The products were also distributed to Poland and Russia. The recall includes government distribution, with no military distribution reported.

Consumers and healthcare facilities should stop using the affected devices and contact Smiths Medical ASD Inc. for instructions on how to return or dispose of the product. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.

The recalled product

Product
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.
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Respiratory / Oxygen Delivery
Hazard
Affected units
850

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 number 1705171A

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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