Class 1 Device Recall Hudson RCI Sheridan LTS:

• Date Initiated by Firm: July 30, 2019
• Date Posted: September 09, 2019
• Recall Status: Terminated on February 15, 2022
• Recall Number: Z-2314-2019
• Recall Event ID: 83461
• 510(K)Number: K822082
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Hudson RCI Sheridan Preformed:; a) 3.0 mm, REF 5-22006, REF 5-22106; b) 3.5 mm, REF 5-22007, REF 5-22107; c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208; d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209; e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210; f) 5.5 mm, REF 5-22011, REF 5-22111, REF 5-22211; g) 6.0 mm, REF 5-22212, REF 5-22312, REF 5-22112; h) 6.5 mm, REF 5-22313, REF 5-22213, REF 5-22013, REF 5-22113; i) 7.0 mm, REF 5-22214, REF 5-22314, REF 5-22014, REF 5-22114; j) 7.5 mm, REF 5-22215, REF 5-22315; k) 8.0 mm, REF 5-22216, REF 5-22316; l) 8.5 mm, REF 5-22217; m) 9.0 mm, REF 5-22218 ; ; Product Usage:; Tracheal tube/airway management
• Code Information: a) REF 5-22006 Batch numbers: 73E1700489 73G1700128 73K1700075 73L1700176 73C1800361 73E1800241 73F1800556 73G1800589 73G1800932 73L1800417 73L1800418 73M1800194 73M1800195 REF 5-22106 Batch numbers: 73E1700719 73M1700260 73E1800567 73J1800524 73K1800731 b) REF 5-22007 Batch numbers: 73L1600002 73K1700426 73A1800460 73D1800648 73E1800565 REF 5-22107 Batch numbers: 73L1600864 73F1700166 73E1800088 73K1800772 c) REF 5-22008 Batch numbers: 73C1700413 73F1700164 73G1700129 73J1700300 73A1800461 73B1800362 73F1800183 REF 5-22108 Batch numbers: 73K1600590 73M1600152 73A1700110 73D1700629 73F1700028 73B1800133 73E1800089 73G1800933 73J1800100 REF 5-22208 Batch numbers: 73L1600360 73A1700112 73D1700258 73F1700032 73F1700725 73G1700605 73H1700786 73J1700478 73K1700275 73K1700740 73L1700508 73M1700263 73A1800316 73A1800816 73B1800493 73C1800365 73D1800147 73E1800091 73E1800569 73F1800557 73H1800679 d) REF 5-22009 Batch numbers: 73L1600003 73C1700414 73D1700640 73F1700026 73G1700130 73H1700610 73K1700274 73A1800066 73C1800464 73D1800649 73E1800566 73F1800340 73L1800633 73L1800822 REF 5-22109 Batch numbers: 73L1600160 73L1600865 73M1600153 73A1700275 73B1700310 73C1700563 73D1700423 73F1700029 73H1700613 73J1700475 73K1700428 73M1700261 73B1800363 73C1800362 73D1800652 73E1800568 73G1800819 73H1800444 73J1800525 73K1800762 73L1800823 REF 5-22209 Batch numbers: 73L1600127 73L1600509 73M1600156 73A1700279 73B1700311 73D1700132 73D1700424 73E1700720 73F1700169 73G1700606 73H1700338 73J1700479 73K1700276 73K1700429 73L1700177 73L1700509 73M1700264 73A1800024 73A1800300 73B1800135 73B1800454 73C1800491 73D1800148 73E1800092 73E1800395 73F1800719 73H1800194 73J1800103 e) REF 5-22010 Batch numbers: 73A1700109 73B1700414 73D1700627 73H1700611 73A1800044 73C1800550 73E1800393 73G1800590 REF 5-22110 Batch numbers: 73K1600591 73L1600161 73L1600866 73A1700111 73A1700276 73B1700416 73C1700251 73C1700693 73F1700030 73G1700425 73J1700476 73L1700333 73M1700262 73B1800453 73C1800363 73E1800090 73F1800343 73G1800820 73H1800445 73K1800733 REF 5-22210 Batch numbers: 73K1600379 73L1600361 73L1600663 73M1600157 73B1700312 73C1700254 73D1700641 73F1700170 73F1700726 73G1700607 73H1700339 73H1700616 73J1700135 73J1700447 73K1700607 73L1700178 73L1700334 73M1700265 73A1800448 73B1800136 73B1800494 73C1800498 73E1800093 73F1800558 f) REF 5-22011 Batch numbers: 73K1600589 73L1600862 73B1700309 73D1700628 73F1700165 73L1700331 73A1800020 73D1800650 73F1800341 REF 5-22111 Batch numbers: 73J1600377 73K1600592 73L1600358 73L1600867 73M1600154 73A1700277 73B1700417 73C1700564 73F1700398 73H1700614 73J1700477 73A1800067 73B1800134 73C1800364 73F1800344 REF 5-22211 Batch numbers: 73K1600380 73K1600729 73L1600664 73B1700420 73C1700255 73D1700133 73D1700642 73F1700033 73F1700727 73G1700608 73H1700340 73H1700787 73J1700136 73J1700480 73K1700430 73K1700741 73L1700510 73M1700266 73A1800301 73A1800449 73B1800137 73B1800495 73C1800177 73D1800149 73E1800094 73F1800184 73F1800559 73L1800437 g) REF 5-22212 Batch 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 REF 5-22312 Batch 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 REF 5-22112 Batch numbers: 73L1600359 73M1600155 73A1700278 73C1700415 73F1700168 73G1700426 73H1700615 73L1700650 73B1800492 73H1800678 73K1800326 73K1800374 h) REF 5-22313 Batch 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 REF 5-22213 Batch numbers: 73K1600149 73L1600666 73A1700114 73B1700314 73C1700694 73D1700644 73F1700400 73G1700428 73H1700342 73H1700788 73J1700482 73K1700277 73L1700180 73L1700512 73M1700268 73A1800451 73B1800496 73D1800151 73E1800571 73F1800346 REF 5-22013 Batch numbers: 73A1700274 73H1700612 73J1700474 REF 5-22113 Batch numbers: 73G1700427 73E1800394 i) REF 5-22214 Batch 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 REF 5-22314 Batch 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 REF 5-22014 Batch numbers: 73F1700027 73K1700427 73F1800342 73K1800182 73K1800730 REF 5-22114 Batch numbers: 73F1700399 73K1800734 j) REF 5-22215 Batch 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 REF 5-22315 Batch 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 k) REF 5-22216 Batch 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 REF 5-22316 Batch numbers: 73C1700260 73C1700795 73F1700402 73H1700345 73H1700790 73L1700517 73B1800501 73D1800477 73F1800353 73G1800824 73H1800755 73K1800192 l) REF 5-22217 Batch numbers: 73L1600163 73L1600363 73C1700796 73F1700555 73H1700343 73J1700140 73L1700515 73M1700148 73A1800025 73A1800303 73B1800366 73B1800724 73E1800397 73F1800349 73J1800529 73L1800828 m) REF 5-22218 Batch numbers: 73F1700556 73G1700430 73H1700619 73J1700301 73F1800350 73G1800138 73J1800108 73J1800530
• Recalling Firm/ Manufacturer: Teleflex Medical; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated July 30, 2019 to affected customers. The letter explains the problem and requests the consignee discontinue use and quarantine of any of the recalled products then to notify Teleflex. The firm is requesting the return of the affected products. For questions, contact your local sales representative or Customer Service at 1-866-396-2111.
• Quantity in Commerce: 278142 units
• Distribution: 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.