Z-1732-2019Class II

Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled...

Name: Z-1732-2019 Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled...
Creator: Smiths Medical ASD Inc.
Published: 2019-02-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-02-11 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2019-02-11. FDA classified it as Class II and gives the reason as "Packaged with an incorrect size inner cannula". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1732-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-11
Posted: 2019-06-04
Terminated: 2020-11-02
Recalling firm: Abbott Medical
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.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: Packaged with an incorrect size inner cannula.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: During the week of February 11, 2019, the firm sent URGENT MEDICAL DEVICE FIELD SAFETY NOTICE emails to their consignees advising them to check their stock, complete an enclosed. INSTRUCTIONS TO CUSTOMERS: 1.Locate and determine the number of affected products in your possession. (Product Number: 100/856/080 Lot Number: 3578884) 2.Complete the attached Response Form within 10 days and return it to [email protected], even if you do not have any of the affected product in your possession. 3.Return affected product to Stericycle utilizing the pre-paid shipping labels included with this notice. Include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit. Ensure boxes are sealed and labeled with your facility name prior to shipping. 4.DISTRIBUTORS: If you have distributed potentially affected devices to your customers, please immediately notify them of this Field Safety Corrective Action. Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may cause. If you have any questions regarding this notification, please contact Smiths Medical via email at [email protected]. FIELD SAFETY NOTICE RESPONSE FORM and return an affected devices to Stericycle. The emails also instructed distributors to conduct a subrecall.
Quantity in commerce: 7,840
Distribution: Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland
Product codes and lots: Item code/product number: 100/856/080 lot number: 3578884

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1732-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1732-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code BTO

K030381Class IIPortex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex , Ltd. / cleared 2003-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)