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Terminated

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

FDA Recall Z-1399-2017 · Posted 2017-03-03

Recalling FirmParker Medical
Recall StatusTerminated
Product CodeCBI
Date Initiated2016-12-16
Date Terminated2017-04-17
Product Quantity1,060 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092886WELL LEAD ENDOBRONCHIAL TUBESWell Lead Instruments · 2010-03-11K984528PARKER FLEX-TIP TRACHEAL TUBEParker Medical Assoc. · 1999-07-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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