Recall Z-1764-2019
Teleflex Medical · initiated May 24, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management
Codes / lots: 1) HVT 6.0 mm, Product Code 5-10312 Lot Numbers: 73J1600355 73J1600564 73J1600751 73K1600137 73K1600571 73L1600138 73L1600338 73L1600488 73L1600650 73L1600838 73M1600133 73A1700091 73A1700254 73A1700721 73B1700136 73B1700296 73B1700402 73B1700617 73C1700402 73C1700678 73D1700127 73E1700093 73E1700460 73F1700137 73F1700538 73F1700703 73G1700218 73G1700591 73H1700318 73H1700473 73H1700778 73J1700127 73J1700460 73J1700594 73K1700057 73K1700409 73K1700587 73K1700725 73L1700498 73M1700240 73M1700450 73A1800284 73A1800442 73A1800665 73A1800810 73B1800342 73B1800702 73C1800188 73C1800564 73D1800059 73D1800133 73D1800305 73D1800456 73D1800629 73E1800072 73E1800381 73E1800785 73F1800163 73F1800707 73G1800118 73G1800218 73G1800568 73G1800799 73G1800911 73H1800184 73H1800420 73J1800072 73H1800724 73J1800663 73K1800163 73K1800369 73K1800456 73L1800799 2) HVT 6.5 mm, Product Code 5-10313 Lot Numbers: 73J1600356 73J1600357 73J1600565 73J1600752 73K1600138 73K1600572 73K1600573 73L1600139 73L1600339 73L1600489 73L1600651 73M1600134 73A1700092 73A1700255 73A1700404 73A1700643 73A1700722 73B1700137 73B1700403 73B1700618 73C1700228 73C1700550 73C1700679 73D1700615 73E1700094 73E1700222 73E1700461…
Reason for recall
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.
FDA-determined cause: Process control
Action taken
Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. For questions contact your local sales representative or Customer Service at 1-866-396-2111
Details
- Recall number
- Z-1764-2019
- Initiated
- May 24, 2019
- Posted by FDA
- June 19, 2019
- Terminated
- February 15, 2022
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Quantity
- 3238600 units
- Distribution
- Worldwide - US Nationwide Distribution
- Recalling firm
- Teleflex Medical, Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1759-2019 Class I | Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1760-2019 Class I | Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1761-2019 Class I | Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1762-2019 Class I | Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c)…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1763-2019 Class I | Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1765-2019 Class I | Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1766-2019 Class I | Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |