Class 1 Device Recall Hudson RCI Sheridan CF

• Date Initiated by Firm: May 24, 2019
• Date Posted: June 19, 2019
• Recall Status: Terminated on February 15, 2022
• Recall Number: Z-1760-2019
• Recall Event ID: 82964
• 510(K)Number: K822082
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Hudson RCI Sheridan:; 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212; 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213; 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214; 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215; 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116; 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217; ; Product Usage:; Tracheal tube/airway management
• Code Information: 1) CF 6.0 mm, Product Codes: a) 5-10112, Lot Numbers: 73J1600560 73J1600743 73K1600130 73K1600565 73L1600008 73L1600325 73L1600642 73L1600830 73M1600126 73A1700085 73A1700246 73A1700717 73B1700288 73B1700395 73B1700615 73C1700223 73C1700397 73C1700541 73D1700236 73D1700610 73E1700217 73E1700454 73E1700698 73F1700532 73G1700137 73G1700214 73G1700585 73H1700033 73H1700466 73J1700125 73J1700277 73J1700588 73K1700053 73K1700249 73K1700394 73K1700582 73L1700166 73L1700306 73L1700521 73L1700659 73M1700133 73M1700445 73A1800042 73A1800281 73A1800662 73B1800114 73B1800474 73B1800700 73C1800183 73C1800469 73D1800300 73D1800624 73E1800061 73E1800225 73E1800779 73F1800157 73F1800529 73F1800697 73G1800115 73G1800212 73G1800562 73G1800791 73H1800178 73H1800652 73J1800082 73J1800317 73J1800496 73J1800656 73K1800359 73L1800193 b) 5-10212, Lot Numbers: 73J1600749 73J1800345 73K1800367 2) CF 6.5 mm, Product Codes: a) 5-10113, Lot Numbers: 73J1600561 73J1600744 73K1600131 73K1600352 73K1600566 73K1600567 73L1600132 73L1600326 73L1600482 73L1600831 73M1600127 73A1700086 73A1700247 73A1700400 73A1700640 73A1700718 73B1700289 73B1700396 73B1700616 73C1700542 73C1700672 73D1700122 73D1700237 73D1700405 73E1700455 73E1700699 73F1700533 73F1700697 73G1700215 73G1700403 73H1700312 73H1700589 73H1700775 73J1700126 73J1700278 73J1700450 73J1700589 73K1700250 73K1700402 73K1700583 73L1700167 73L1700307 73L1700522 73L1700660 73M1700134 73M1700446 73A1800038 73A1800663 73B1800115 73B1800475 73B1800701 73C1800184 73C1800336 73C1800559 73D1800060 73D1800301 73D1800625 73E1800069 73E1800226 73E1800376 73E1800780 73F1800158 73F1800324 73F1800530 73F1800698 73G1800213 73H1800179 73J1800318 73K1800360 b) 5-10213, Lot Numbers: 73A1700252 73D1700241 73J1700458 73B1800339 3) CF 7.0 mm, Product Codes: a) 5-10114, Lot Numbers: 73J1600745 73J1600746 73J1600747 73K1600132 73K1600720 73L1600327 73L1600328 73L1600832 73L1600833 73M1600272 73A1700087 73A1700088 73B1700290 73B1700291 73B1700292 73B1700293 73B1700397 73C1700398 73C1700399 73C1700400 73C1700543 73C1700544 73C1700545 73C1700546 73D1700611 73E1700088 73E1700089 73E1700090 73E1700700 73F1700143 73F1700138 73F1700534 73F1700535 73F1700698 73G1700144 73G1700145 73G1700216 73G1700586 73G1700587 73H1700034 73H1700467 73H1700590 73J1700149 73J1700150 73J1700279 73J1700590 73K1700054 73K1700055 73K1700056 73K1700251 73K1700584 73K1700720 73M1700236 73M1700237 73M1700427 73M1700428 73A1800439 73A1800440 73A1800441 73B1800220 73B1800221 73B1800222 73B1800219 73B1800335 73B1800336 73C1800337 73C1800338 73C1800339 73C1800470 73C1800471 73C1800472 73C1800473 73D1800448 73D1800449 73D1800450 73D1800626 73D1800627 73E1800544 73E1800545 73E1800781 73F1800112 73F1800531 73F1800532 73F1800699 73F1800700 73F1800701 73G1800116 73G1800117 73G1800214 73H1800180 73H1800715 73J1800084 73J1800498 73J1800499 73J1800657 73L1800511 73K1800714 73K1800715 b) 5-10214, Lot Numbers: 73K1600136 73K1600722 73L1600334 73L1600405 73M1600269 73C1700401 73D1700614 73F1700144 73G1700124 73H1700036 73M1700204 73M1700429 73A1800297 73B1800340 73C1800343 73D1800628 73E1800547 73F1800705 73H1800720 73J1800086 73J1800660 4) CF 7.5 mm, Product Codes: a) V5-10115, Lot Numbers: 73J1600386 73L1600171 73L1600517 73M1600276 73B1700164 73C1700701 73D1700264 73E1700505 73G1700435 73H1700054 73H1700795 73K1700280 73K1700752 73B1800511 73D1800157 73E1800097 73E1800234 73F1800361 73G1800594 73H1800204 73H1800687 73J1800119 73K1800323 b) 5-10115, Lot Numbers: 73J1600562 73K1600133 73K1600134 73L1600133 73L1600483 73L1600645 73M1600128 73A1700248 73A1700719 73A1700720 73B1700131 73B1700132 73B1700626 73B1700627 73C1700224 73C1700225 73C1700226 73C1700673 73C1700674 73D1700123 73D1700124 73D1700238 73E1700218 73E1700219 73E1700220 73E1700456 73F1700369 73F1700370 73F1700371 73G1700217 73G1700404 73H1700035 73H1700313 73H1700591 73H1700776 73J1700280 73J1700451 73K1700252 73K1700253 73K1700403 73K1700404 73K1700721 73L1700191 73L1700308 73L1700309 73M1700447 73M1700448 73A1800656 73A1800796 73A1800797 73B1800476 73B1800477 73B1800478 73C1800561 73D1800126 73D1800127 73D1800128 73D1800287 73E1800063 73E1800070 73E1800222 73E1800366 73E1800367 73F1800159 73F1800160 73F1800302 73F1800325 73F1800326 73F1800533 73F1800534 73G1800563 73G1800795 73G1800796 73G1800794 73H1800074 73H1800181 73H1800653 73H1800716 73J1800085 73J1800328 73J1800500 73K1800324 73K1800361 73K1800362 73K1800535 73K1800536 73L1800263 c) 5-10215, Lot Numbers: 73M1600131 73H1700316 73L1700310 73M1700436 73B1800452 73E1800368 73F1800327 73G1800555 73H1800182 73H1800721 73J1800087 73K1800368 5) CF 8.0 mm, Product Codes: a) 5-10116, Lot Numbers: 73J1600563 73J1600678 73J1600748 73K1600569 73L1600134 73L1600329 73L1600330 73L1600404 73L1600646 73L1600834 73M1600129 73A1700650 73B1700398 73B1700628 73D1700239 73D1700412 73D1700413 73D1700414 73D1700612 73F1700009 73F1700010 73F1700699 73F1700700 73G1700405 73G1700588 73H1700314 73H1700468 73J1700145 73J1700452 73J1700591 73K1700395 73K1700585 73M1700026 73M1700135 73M1700136 73A1800048 73A1800049 73A1800050 73A1800387 73B1800709 73B1800710 73C1800185 73D1800289 73D1800451 73E1800782 73F1800019 73F1800018 73G1800215 73G1800565 73G1800564 73H1800432 73H1800433 73H1800692 73J1800329 73J1800501 73J1800650 73K1800158 73K1800159 73K1800228 b) 5-10216, Lot Numbers: 73J1600750 73L1600335 73L1600648 73B1700401 73D1700242 73F1700012 73F1700701 73G1700409 73H1700317 73J1700147 73J1700592 73A1800052 73B1800712 73G1800217 73J1800331 73J1800661 73K1800162 c) V5-10116, Lot Numbers: 73J1600771 73L1600172 73L1600671 73B1700427 73D1700265 73F1700037 73F1700733 73G1700436 73H1700351 73J1700146 73J1700608 73K1700088 73M1700027 73A1800248 73B1800692 73C1800204 73D1800482 73F1800020 73G1800233 73H1800455 73H1800689 73J1800330 73K1800194 6) CF 8.5 mm, Product Codes: a) 5-10117, Lot Numbers: 73L1600331 73L1600647 73C1700675 73D1700613 73F1700528 73G1700406 73H1700315 73J1700281 73B1800711 73C1800562 73F1800161 73G1800910 73J1800008 73J1800502 73K1800537 b) 5-10217, Lot Numbers: 73B1800713 73F1800162 73J1800506 73K1800538
• 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: 1101073 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.