Parker Left Double Lumen Endobronchial Tube with Parker… recallZ-1399-2017 · Parker Medical · initiated Dec 16, 2016
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Parker Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1399-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 16, 2016
- Posted by the FDA
- Mar 3, 2017
- Recalling firm
- Parker Medical
- Quantity
- 1,060 units
- Product code
- CBI
- FDA submissions
- K092886, K984528
- Distribution
- Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.
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
Code information (models, lots, serial numbers)
Lot Numbers: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F
Other devices under the same FDA submission
11 devices cleared under K092886, K984528 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Parker H-PFHV-75Salter Labs · Tube, Tracheal (W/Wo Connector)1 death19 reports
- Parker H-PFHV-80Salter Labs · Tube, Tracheal (W/Wo Connector)12 reports
- Parker H-PFHV-70Salter Labs · Tube, Tracheal (W/Wo Connector)11 reports
- Parker H-PSTDL-37Salter Labs · Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)10 reports
- Parker H-PFST-70Salter Labs · Tube, Tracheal (W/Wo Connector)1 death5 reports
- Parker H-PFST-75Salter Labs · Tube, Tracheal (W/Wo Connector)3 reports
- Parker H-PSTDL-35Salter Labs · Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2 reports
- Parker H-PFHV-85Salter Labs · Tube, Tracheal (W/Wo Connector)1 report
- Parker H-PTCL-35Salter Labs · Tube, Tracheal (W/Wo Connector)1 report
- Parker H-PFST-80Salter Labs · Tube, Tracheal (W/Wo Connector)1 report
- Parker H-PSTDL-32Salter Labs · Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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