PlainRecalls
FDA Devices Moderate Class II Ongoing

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

Reported: August 25, 2021 Initiated: July 16, 2021 #Z-2321-2021

Product Description

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

Reason for Recall

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Details

Units Affected
2610 units
Distribution
US Nationwide distribution.
Location
Athlone, N/A

Frequently Asked Questions

What product was recalled?
RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100. Recalled by Teleflex Medical Europe Ltd. Units affected: 2610 units.
Why was this product recalled?
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2321-2021.