Z-1641-2014Class I

Portex Low Dead Space Connector with Sideport, 3.5mm

Name: Z-1641-2014 Portex Low Dead Space Connector with Sideport, 3.5mm
Creator: Smiths Medical ASD, Inc.
Published: 2014-04-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-04-10 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The... on 2014-04-10. FDA classified it as Class I and gives the reason as "One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1641-2014
Classification: Class I
Status: Terminated
Initiated: 2014-04-10
Posted: 2014-06-11
Terminated: 2016-11-29
Recalling firm: Abbott Medical
Product: Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration of artificial surfactant, airway pressure monitoring, gas sampling, and instillation of sterile saline for airway leakage.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Smiths Medical sent an Urgent Medical Device Recall Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine all affected products and to complete the attached Response Form and return it to Smith Medical within 7 days of receipt of the notice. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at +1-800-258-5361.
Quantity in commerce: 100 devices
Distribution: US distribution in the state of North Carolina.
Product codes and lots: Lot or Serial No: 2553426

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1641-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1641-2014	Class I	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-11

Product code BTR

K790312Class IIEndotracheal Tube W/holder & ConnectorRespiratory Support Products, Inc. / cleared 1979-02-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)