Device product
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
Z-1765-2019
Product summary
- Firm
- Teleflex Medical
- Event
- Event 82964
- Status
- Terminated
- Classification
- Class I
- Quantity
- 77136 units
- Official record key
device-enforcement:Z-1765-2019
Official wording
Reason: This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Code information: Lot Numbers: 73K1600156 73K1600735 73L1600501 73A1700120 73B1700321 73C1700425 73D1700630 73E1700504 73G1700146 73H1700053 73J1700307 73K1700085 73B1800223 73B1800371 73C1800372 73D1800655 73E1800579 73G1800627 73H1800203 73H1800429 73H1800758 73J1800118 73J1800696
Distribution pattern: Worldwide - US Nationwide Distribution
Derived failure modes
-
Unknown
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.