Recall Z-1765-2019
Teleflex Medical · initiated May 24, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
Codes / lots: 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
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-1765-2019
- Initiated
- May 24, 2019
- Posted by FDA
- June 19, 2019
- Terminated
- February 15, 2022
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Quantity
- 77136 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-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 |