Z-1399-2017Class II

Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model...

Name: Z-1399-2017 Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model...
Creator: Parker Medical
Published: 2016-12-16
License: https://open.fda.gov/license/

Parker Medical / initiated 2016-12-16 / Terminated

FDA source

Parker Medical began a recall of Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1... on 2016-12-16. FDA classified it as Class II and gives the reason as "The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1399-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Posted: 2017-03-03
Terminated: 2017-04-17
Recalling firm: Parker Medical
Product: Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries
Product code: CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Reason for recall: The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
FDA root cause: Under Investigation by firm
Action: Parker Medical notified consignees via telephone on December 16, 2016. Consignees were instructed to segregate affected products for immediate pick up. For questions regarding this recall call 239-307-6064.
Quantity in commerce: 1,060 units
Distribution: Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.
Product codes and lots: Lot Numbers: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1399-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1399-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-03

Product code CBI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)