Class 1 Device Recall Hudson RCI Sheridan Preformed

• Date Initiated by Firm: May 24, 2019
• Date Posted: June 19, 2019
• Recall Status: Terminated on February 15, 2022
• Recall Number: Z-1762-2019
• Recall Event ID: 82964
• 510(K)Number: K822082
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Hudson RCI Sheridan:; 1) Preformed 6.0 mm, Product Codes: ; a) 5-22212, ; b) 5-22312, ; c) 5-22112, ; d) 5-22012,; ; 2) Preformed 6.5 mm, Product Codes: ; a) 5-22313, ; b) 5-22213, ; c) 5-22013, ; d) 5-22113,; ; 3) Preformed 7.0 mm, Product Codes: ; a) 5-22214, ; b) 5-22314, ; c) 5-22014, ; d) 5-22114,; ; 4) Preformed 7.5 mm, Product Codes: ; a) 5-22215, ; b) 5-22315,; ; 5) Preformed 8.0 mm, Product Codes: ; a) 5-22216, ; b) 5-22316,; ; 6) Preformed 8.5 mm, Product Codes: 5-22217; ; ; Product Usage:; Tracheal tube/airway management
• Code Information: Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, Lot Numbers: 73J1600378 73K1600730 73L1600665 73M1600158 73B1700049 73B1700313 73C1700416 73D1700643 73F1700034 73F1700171 73F1700728 73G1700609 73H1700341 73J1700481 73J1700681 73K1700431 73L1700179 73L1700511 73M1700267 73A1800302 73A1800450 73B1800138 73C1800551 73D1800150 73E1800570 73F1800345 73H1800196 73J1800290 73K1800186 b) 5-22312, Lot Numbers: 73K1600151 73L1600512 73M1600159 73A1700737 73B1700423 73C1700697 73D1700426 73E1700561 73E1700721 73F1700173 73F1700730 73G1700612 73H1700620 73J1700141 73J1700484 73K1700078 73K1700433 73K1700744 73L1700516 73A1800023 73B1800140 73B1800500 73C1800328 73D1800474 73E1800398 73F1800561 73G1800139 73H1800683 73J1800109 73K1800188 c) 5-22112, Lot Numbers: 73L1600359 73M1600155 73A1700278 73C1700415 73F1700168 73G1700426 73H1700615 73L1700650 73B1800492 73H1800678 73K1800326 73K1800374 d) 5-22012, Lot Numbers: 73L1600863 73E1700491 73L1700332 73D1800651 73J1800335 2) Preformed 6.5 mm, Product Codes: a) 5-22313, Lot Numbers: 73J1600382 73K1600384 73K1600732 73L1600668 73M1600160 73A1700116 73A1700738 73C1700698 73D1700647 73E1700760 73F1700401 73G1700613 73H1700621 73J1700485 73K1700079 73K1700434 73K1700745 73M1700270 73A1800304 73B1800367 73C1800368 73D1800292 73E1800399 73F1800351 73G1800140 73G1800821 b) 5-22213, Lot Numbers: 73K1600149 73L1600666 73A1700114 73B1700314 73C1700694 73D1700644 73F1700400 73G1700428 73H1700342 73H1700788 73J1700482 73K1700277 73L1700180 73L1700512 73M1700268 73A1800451 73B1800496 73D1800151 73E1800571 73F1800346 c) 5-22013, Lot Numbers: 73A1700274 73H1700612 73J1700474 d) 5-22113, Lot Numbers: 73G1700427 73E1800394 3) Preformed 7.0 mm, Product Codes: a) 5-22214, Lot Numbers: 73J1600379 73K1600593 73L1600667 73B1700315 73C1700695 73D1700425 73E1700493 73G1700429 73H1700493 73J1700137 73K1700076 73K1700608 73L1700335 73M1700269 73M1700459 73A1800452 73B1800364 73B1800497 73C1800366 73D1800472 73E1800572 73F1800347 73G1800935 73H1800447 73H1800681 73J1800106 b) 5-22314, Lot Numbers: 73J1600383 73L1600164 73L1600868 73M1600161 73A1700117 73A1700739 73C1700566 73D1700648 73F1700065 73F1700731 73G1700431 73H1700622 73J1700142 73K1700080 73K1700746 73M1700461 73A1800455 73B1800141 73B1800456 73D1800153 73D1800475 73E1800574 73F1800352 73G1800141 73G1800822 73J1800111 73K1800190 c) 5-22014, Lot Numbers: 73F1700027 73K1700427 73F1800342 73K1800182 73K1800730 d) 5-22114, Lot Numbers: 73F1700399 73K1800734 4) Preformed 7.5 mm, Product Codes: a) 5-22215, Lot Numbers: 73J1600380 73K1600150 73C1700257 73C1700565 73D1700645 73E1700494 73F1700729 73G1700610 73H1700617 73J1700138 73J1700483 73K1700432 73K1700742 73L1700513 73M1700146 73A1800453 73B1800365 73B1800498 73C1800367 73D1800473 73E1800396 73F1800185 73F1800560 73J1800527 b) 5-22315, Lot Numbers: 73J1600384 73L1600869 73M1600162 73C1700417 73D1700134 73D1700649 73F1700174 73F1700732 73H1700344 73H1700789 73J1700486 73K1700278 73M1700271 73A1800022 73A1800456 73B1800142 73C1800369 73D1800476 73E1800400 73G1800142 73G1800823 73H1800685 73J1800112 73J1800690 73K1800191 5) Preformed 8.0 mm, Product Codes: a) 5-22216, Lot Numbers: 73J1600381 73K1600383 73L1600162 73L1600511 73A1700115 73A1700736 73B1700422 73C1700258 73C1700696 73D1700646 73E1700495 73F1700172 73F1700554 73G1700611 73H1700618 73J1700139 73K1700743 73L1700514 73M1700147 73M1700460 73A1800454 73B1800139 73B1800499 73D1800152 73E1800573 73F1800348 73G1800137 73H1800682 73J1800107 73J1800528 b) 5-22316, Lot Numbers: 73C1700260 73C1700795 73F1700402 73H1700345 73H1700790 73L1700517 73B1800501 73D1800477 73F1800353 73G1800824 73H1800755 73K1800192 6) Preformed 8.5 mm, Product Codes: 5-22217 Lot Numbers: 73L1600163 73L1600363 73C1700796 73F1700555 73H1700343 73J1700140 73L1700515 73M1700148 73A1800025 73A1800303 73B1800366 73B1800724 73E1800397 73F1800349 73J1800529 73L1800828
• 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: 186592 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.