Class 1 Device Recall Hudson RCI Sheridan HVT

• Date Initiated by Firm: May 24, 2019
• Date Posted: June 19, 2019
• Recall Status: Terminated on February 15, 2022
• Recall Number: Z-1764-2019
• Recall Event ID: 82964
• 510(K)Number: K822082
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Hudson RCI Sheridan:; 1) HVT 6.0 mm, Product Code 5-10312; 2) HVT 6.5 mm, Product Code 5-10313; 3) HVT 7.0 mm, Product Code 5-10314; 4) HVT 7.5 mm, Product Code 5-10315; 5) HVT 8.0 mm, Product Code 5-10316; 6) HVT 8.5 mm, Product Code 5-10317; ; Product Usage:; Tracheal tube/airway management
• Code Information: 1) HVT 6.0 mm, Product Code 5-10312 Lot 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 2) HVT 6.5 mm, Product Code 5-10313 Lot 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 3) HVT 7.0 mm, Product Code 5-10314 Lot 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 73G1800121 73G1800149 73G1800220 73G1800487 73G1800636 73G1800637 73G1800638 73G1800913 73G1800914 73G1800915 73H1800422 73H1800726 73J1800088 73J1800089 73J1800354 73J1800509 73J1800510 73J1800508 73J1800651 73J1800665 4) HVT 7.5 mm, Product Code 5-10315 Lot Numbers: 73J1600361 73J1600362 73J1600566 73J1600567 73L1600492 73L1600652 73L1600653 73L1600686 73M1600136 73M1600137 73M1600267 73A1700257 73A1700258 73A1700405 73A1700724 73B1700140 73B1700631 73B1700632 73C1700229 73C1700230 73C1700231 73C1700682 73C1700707 73D1700140 73D1700244 73D1700245 73D1700268 73E1700223 73E1700224 73E1700225 73E1700464 73E1700465 73E1700466 73F1700279 73F1700377 73F1700378 73F1700379 73F1700376 73G1700203 73G1700223 73G1700413 73G1700414 73H1700320 73H1700303 73H1700597 73H1700780 73J1700462 73J1700463 73K1700259 73K1700411 73K1700412 73K1700729 73L1700312 73L1700313 73L1700314 73L1700315 73M1700430 73A1800431 73A1800667 73A1800668 73A1800669 73A1800670 73A1800794 73B1800481 73B1800714 73C1800568 73D1800135 73D1800136 73D1800285 73D1800307 73E1800076 73E1800228 73E1800384 73E1800385 73F1800164 73F1800329 73F1800330 73F1800537 73F1800538 73F1800539 73F1800540 73G1800570 73G1800802 73G1800803 73G1800917 73G1800918 73G1800919 73H1800072 73H1800073 73H1800186 73H1800659 73H1800660 73H1800727 73J1800090 73J1800325 73J1800326 73K1800164 73K1800321 73K1800351 73K1800352 5) HVT 8.0 mm, Product Code 5-10316 Lot Numbers: 73J1600568 73J1600755 73K1600577 73L1600143 73L1600341 73L1600342 73L1600343 73L1600555 73L1600654 73L1600841 73L1600842 73A1700413 73A1700414 73A1700654 73B1700408 73B1700619 73B1700620 73D1700246 73D1700416 73D1700417 73D1700418 73D1700617 73D1700618 73E1700707 73E1700708 73F1700018 73F1700563 73F1700706 73F1700707 73F1700708 73G1700415 73G1700416 73G1700593 73G1700594 73H1700321 73H1700477 73H1700781 73J1700444 73J1700464 73J1700598 73K1700413 73K1700590 73K1700591 73M1700122 73M1700123 73M1700124 73A1800053 73A1800054 73B1800693 73C1800189 73C1800190 73C1800191 73D1800290 73D1800458 73D1800459 73E1800788 73E1800789 73F1800071 73G1800221 73G1800222 73G1800639 73G1800571 73G1800572 73H1800435 73H1800436 73H1800661 73H1800662 73J1800332 73J1800333 73J1800666 73K1800124 73K1800165 73K1800166 73K1800167 73K1800227 73L1800480 6) HVT 8.5 mm, Product Code 5-10317 Lot Numbers: 73K1600364 73L1600344 73L1600655 73C1700683 73D1700619 73F1700544 73G1700417 73H1700322 73J1700286 73M1700024 73A1800299 73B1800716 73C1800569 73F1800165 73G1800920 73J1800511 73K1800546
• Recalling Firm/ Manufacturer: Teleflex Medical; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer 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: 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
• Quantity in Commerce: 3238600 units
• Distribution: Worldwide - US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BTR and Original Applicant = SHERIDAN CATHETER CORP.