FDA Recall
Open, Classified
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
Recall: Z-2321-2021
·
Initiated July 16, 2021
Recall
- Recall Number
- Z-2321-2021
- Event Number
- 88353
- Firm
- Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland
- FEI Number
- 3007134520
- Product Code
- BTR
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- July 16, 2021
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
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Action
The firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers.
Distribution
US Nationwide distribution.
Quantity
2610 units