FDAFDA · Food and drugs·Recall number Z-2316-2019
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management
Published September 18, 2019 · Recall initiated: July 30, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- US Nationwide Distribution
- Lot
- a) REF 5-10310 Batch numbers: 73K1600356 73L1600336 73L1600486 73L1600836 73M1600132 73B1700134 73C1700227 73C1700676 73D1700243 73E1700091 73F1700013 73F1700145 73F1700702 73G1700410 73H1700471 73H1700777 73J1700593 73K1700254 73K1700723 73L1700661 73A1800282 73A1800664 73B1800341 73C1800186 73C1800563 73D1800303 73D1800454 73E1800071 73E1800378 73F1800706 73G1800567 73K1800540 73K1800541 b) REF 5-10311 Batch numbers: 73K1600357 73L1600337 73L1600487 73L1600837 73A1700253 73C1700677 73D1700126 73E1700092 73E1700459 73E1700221 73F1700374 73G1700411 73G1700590 73H1700472 73J1700459 73K1700255 73K1700724 73M1700239 73A1800283 73A1800809 73C1800187 73D1800132 73D1800304 73D1800455 73E1800379 73E1800784 73F1800536 73H1800183 c) REF 5-10312 Batch 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 d) REF 5-10313 Batch 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 73F1700014 73F1700375 73F1700539 73F1700704 73G1700412 73H1700319 73H1700474 73H1700594 73J1700283 73J1700461 73J1700595 73K1700058 73K1700410 73K1700588 73K1700726 73L1700311 73L1700499 73L1700662 73M1700241 73M1700425 73M1700451 73A1800043 73A1800285 73A1800666 73B1800117 73B1800480 73B1800703 73C1800476 73D1800134 73D1800306 73D1800457 73E1800073 73E1800227 73E1800548 73F1800328 73F1800708 73G1800119 73G1800219 73G1800800 e) REF 5-10314 Batch numbers: 73J1600358 73J1600359 73J1600360 73J1600753 73J1600754 73K1600139 73K1600140 73K1600141 73K1600142 73K1600359 73K1600360 73K1600576 73K1600574 73K1600575 73K1600723 73L1600340 73L1600490 73L1600491 73L1600839 73L1600840 73M1600135 73A1700093 73A1700094 73A1700095 73B1700138 73B1700139 73B1700297 73B1700404 73B1700405 73B1700406 73B1700407 73C1700403 73C1700404 73C1700551 73C1700552 73C1700680 73C1700681 73D1700616 73E1700095 73E1700096 73E1700242 73E1700462 73E1700463 73E1700703 73E1700705 73E1700706 73F1700015 73F1700016 73F1700146 73F1700147 73F1700148 73F1700149 73F1700540 73F1700541 73F1700542 73F1700543 73F1700705 73G1700143 73G1700125 73G1700220 73G1700221 73G1700222 73G1700219 73G1700592 73H1700024 73H1700025 73H1700475 73H1700476 73H1700595 73H1700596 73J1700148 73J1700284 73J1700285 73J1700596 73K1700059 73K1700256 73K1700257 73K1700258 73K1700589 73K1700727 73L1700223 73M1700205 73M1700242 73M1700243 73M1700244 73M1700426 73M1700437 73M1700438 73A1800293 73A1800294 73A1800295 73A1800429 73A1800798 73A1800799 73B1800343 73B1800344 73B1800345 73C1800344 73C1800345 73C1800346 73C1800477 73C1800565 73C1800566 73C1800567 73D1800630 73D1800631 73D1800632 73E1800074 73E1800075 73E1800382 73E1800383 73E1800549 73E1800550 73E1800786 73E1800787 73F1800709 73F1800711 73F1800710 73G1800120
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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