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Recall Observatory FDA recall evidence

Device 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.

Z-0071-2019

July 06, 2018

Class III

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 80635
Status
Terminated
Classification
Class III
Quantity
12,000 devices
Official record key
device-enforcement:Z-0071-2019

Official wording

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

Code information: Lot numbers 1703221A and 1705111A

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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labels are transposed