Reported Mar 15, 2017 · Terminated
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers:…
Parker Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Parker Medical · 5085 Weeping Willow Cir · Highlands Ranch, CO · 80130-4485
Is this the product you have?
- Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip)
- Model NumbersH-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
- Lot codes and dates
- Lot Numbers
1605DL0814A1605DL0814B1601LD2001C1605DL0814C1601DL2001D1605DL0814D1601DL2001E1605DL0814E1605DL0814F
- Lot Numbers
- Amount recalled
- 1,060 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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