Recall Z-1763-2019
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) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
Codes / lots: 1) Uncuffed 6.0 mm, Product Code 5-10412 Lot Numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923 2) Uncuffed 6.5 mm, Product Code 5-10413 Lot Numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 3) Uncuffed 7.0 mm, Product Code 5-10414 Lot Numbers: 73A1700100 73F1700064 73L1800406
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-1763-2019
- Initiated
- May 24, 2019
- Posted by FDA
- June 19, 2019
- Terminated
- February 15, 2022
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Quantity
- 14357
- 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-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 |
| 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 |