Recall Z-1766-2019
Teleflex Medical · initiated May 24, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management
Codes / lots: 1) Novaplus 7.0 mm, Product Code V5-10314 Lot Numbers: 73J1600387 73J1600388 73K1600157 73K1600603 73K1600604 73K1600736 73L1600367 73L1600368 73L1600502 73L1600870 73M1600165 73M1600270 73A1700121 73A1700122 73B1700322 73B1700428 73C1700426 73C1700576 73C1700577 73C1700702 73C1700703 73E1700106 73E1700107 73E1700108 73E1700239 73F1700560 73G1700147 73G1700148 73G1700302 73G1700303 73G1700623 73G1700624 73H1700055 73H1700497 73H1700568 73H1700628 73J1700309 73K1700086 73K1700087 73K1700616 73A1800296 73A1800430 73B1800218 73B1800372 73B1800373 73B1800374 73B1800512 73B1800513 73C1800373 73C1800574 73C1800575 73D1800656 73D1800657 73E1800580 73E1800581 73E1800809 73F1800723 73G1800107 73H1800205 73H1800456 73H1800457 73H1800759 73H1800760 73J1800120 73J1800534 73J1800697 2) Novaplus 7.5 mm, Product Code V5-10315 Lot Numbers: 73J1600389 73J1600580 73J1600581 73K1600158 73L1600260 73L1600518 73L1600672 73M1600268 73A1700289 73A1700290 73A1700741 73B1700165 73B1700638 73C1700265 73D1700137 73D1700138 73D1700266 73D1700267 73E1700240 73F1700281 73F1700365 73F1700414 73G1700237 73G1700437 73H1700056 73H1700352 73H1700629 73H1700796 73J1700443 73K1700435 73K1700436 73K1700754 73L1700672…
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-1766-2019
- Initiated
- May 24, 2019
- Posted by FDA
- June 19, 2019
- Terminated
- February 15, 2022
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Quantity
- 1390944 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-1764-2019 Class I | Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code…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 |