Smiths Medical ASD Inc. recalls smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIR…

Recall date

July 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0143-2025

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

Worldwide distribution.

Why it was recalled

Uncertainty in the seal integrity of the sterile packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;