Parker Medical: Medical Device Recall in 2017 - (Recall #: Z-1399-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 16, 2016

Date Posted: March 15, 2017

Recall Number: Z-1399-2017

Event ID: 76299

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.

Status: Terminated

Product Quantity: 1,060 units

Code Information:

Lot Numbers: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F

Distribution Pattern:

Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.

Voluntary or Mandated:

Voluntary: Firm initiated