Teleflex Medical: Medical Device Recall in 2019 - (Recall #: Z-1761-2019)

Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management

Class I

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.

1) EZ-ENDO 6.0 mm, Product Code 5-22512 Lot Numbers: 73K1600152 73M1600163 73A1700280 73C1700567 73E1700496 73F1700403 73H1700347 73M1700272 73E1800401 73E1800575 73F1800354 2) EZ-ENDO 6.5 mm, Product Code 5-22513 Lot Numbers: 73J1600766 73B1700155 73C1700568 73F1700404 73G1700432 73H1700348 73E1800576 73F1800355 3) EZ-ENDO 7.0 mm, Product Code 5-22514 Lot Numbers: 73A1700118 73C1700569 73E1700722 73F1700175 73F1700405 73G1700433 73H1700349 73H1700494 73H1700711 73J1700143 73K1700081 73K1700610 73L1700181 73M1700273 73D1800653 73F1800562 73F1800720 73H1800450 73J1800531 73K1800328 73K1800786 4) EZ-ENDO 7.5 mm, Product Code 5-22515 Lot Numbers: 73B1700316 73C1700262 73C1700418 73E1700723 73E1700104 73F1700176 73F1700406 73G1700434 73H1700350 73J1700302 73J1700497 73K1700747 73M1700274 73A1800068 73A1800683 73B1800502 73C1800201 73D1800154 73E1800402 73F1800565 73G1800591 73H1800451 73H1800686 73J1800113 73K1800736 5) EZ-ENDO 8.0 mm, Product Code 5-22516 Lot Numbers: 73K1600594 73A1700282 73B1700158 73B1700317 73C1700570 73F1700036 73F1700177 73F1700407 73G1700614 73H1700495 73J1700487 73K1700082 73A1800684 73B1800503 73C1800371 73E1800577 73G1800232 73J1800532 73K1800327 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Lot Numbers: 73J1600767 73C1800202

Worldwide - US Nationwide Distribution

Voluntary: Firm initiated