FDAFDA · Food and drugs·Recall number Z-1399-2017
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
Published March 15, 2017 · Recall initiated: December 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Parker Medical
- Distributor
- Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.
- Lot
- Lot Numbers: 1605DL0814A, 1605DL0814B, 1601LD2001C, 1605DL0814C, 1601DL2001D, 1605DL0814D, 1601DL2001E, 1605DL0814E, 1605DL0814F
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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