The Recall Desk

FDA (Devices) recall action 80635

Smiths Medical ASD Inc. recalled 5 products on 2018-10-10

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-10-10
Critical
0
Units
32,150

Why these products were recalled

"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • LowFDA (Devices)··2018-10-10

    Smiths Medical Portex Nasal Oxygen Cannula Recall for Labeling Error

    Smiths Medical ASD Inc. is recalling 13,750 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.

    Product
    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.
    Category
    Distribution
    15 states
  • LowFDA (Devices)··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.

    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.
    Category
    Distribution
    15 states
  • LowFDA (Devices)··2018-10-10

    Smiths Medical Nasal Cannula Recalled for Incorrect Labeling

    Smiths Medical ASD Inc. is recalling 2,550 adult nasal cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expired before it was manufactured.

    Product
    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.
    Category
    Distribution
    15 states
  • LowFDA (Devices)··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.

    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.
    Category
    Distribution
    15 states
  • LowFDA (Devices)··2018-10-10

    Smiths Medical Nasal Cannula Recalled for Transposed Date Labels

    Smiths Medical ASD Inc. is recalling 12,000 First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.

    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.
    Category
    Distribution
    15 states