RecallRadar

FDA Device recall Z-1732-2019

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula

On 2019-06-12 the FDA classified a Class II recall of Portex Blue Line Ultra Tracheostomy Tube Inner Cannula by Smiths Medical Asd, citing packaged with an incorrect size inner cannula.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1732-2019
ClassificationClass II
Statusterminated
Initiated2019-02-11
Published2019-06-12
Last updated2026-09-13 11:55 UTC
CompanySmiths Medical Asd
DistributionUS

Product

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

Reason

Packaged with an incorrect size inner cannula.

Identifiers

code_infoItem code/product number: 100/856/080 lot number: 3578884

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1732-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.