Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip — Class II medical device recall Z-1399-2017
Terminated recall by Parker Medical, reported 2017-03-15, distributed nationwide. The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single
| Recall number | Z-1399-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Parker Medical, Highlands Ranch, CO, United States |
| Recall initiated | 2016-12-16 |
| Classified | 2017-03-03 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,060 units |
| Lot numbers | 1601DL2001D, 1601DL2001E, 1601LD2001C, 1605DL0814A, 1605DL0814B, 1605DL0814C, 1605DL0814D, 1605DL0814E, 1605DL0814F |
| 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 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1399-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.