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U.S. Department of Health and Human Services

Class 1 Device Recall Hudson RCI Sheridan LTS:

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  Class 1 Device Recall Hudson RCI Sheridan LTS: see related information
Date Initiated by Firm July 30, 2019
Date Posted September 09, 2019
Recall Status1 Terminated 3 on February 15, 2022
Recall Number Z-2315-2019
Recall Event ID 83461
510(K)Number K822082  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product Hudson RCI Sheridan Uncuffed:
a) 2.0 mm, REF 5-10404
b) 2.5 mm, REF 5-10405
c) 3.0 mm, REF 5-10406
d) 3.5 mm, REF 5-10407
e) 4.0 mm, REF 5-10408
f) 4.5 mm, REF 5-10409
g) 5.0 mm, REF 5-10410
h) 5.5 mm, REF 5-10411
i) 6.0 mm, REF 5-10412
j) 6.5 mm, REF 5-10413
k) 7.0 mm, REF 5-10414

Product Usage:
Tracheal tube/airway management
Code Information a) REF 5-10404 Batch numbers: 73L1600844 73A1700096 73A1700260 73B1700298 73C1700405 73F1700381 73F1700710 73H1700323 73H1700478 73M1700246 73A1800055 73B1800120 73E1800552 73J1800091 73L1800610  b) REF 5-10405 Batch numbers: 73L1600845 73A1700097 73A1700725 73B1700299 73F1700712 73G1700418 73H1700038 73H1700479 73J1700287 73A1800056 73A1800462 73B1800121 73E1800553 73F1800713 73H1800423 73H1800664 73K1800376  c) REF 5-10406 Batch numbers: 73L1600495 73B1700621 73D1700622 73E1700710 73F1700152 73G1700131 73H1700480 73J1700128 73J1700599 73K1700594 73L1700318 73M1700139 73M1700415 73A1800057 73A1800463 73A1800811 73B1800484 73C1800192 73D1800310 73D1800462 73E1800386 73E1800790 73F1800541 73G1800576 73H1800189 73H1800665 73J1800092 73L1800209 73L1800404 73L1800513 73L1800611 73L1800727 73M1800178 73M1800342  d) REF 5-10407 Batch numbers: 73K1600366 73L1600643 73A1700261 73D1700408 73G1700419 73H1700039 73K1700261 73K1700595 73M1700416 73A1800812 73C1800175 73E1800229 73F1800542 73G1800921 73K1800549  e) REF 5-10408 Batch numbers: 73K1600725 73L1600656 73B1700143 73C1700554 73D1700409 73E1700226 73E1700711 73F1700383 73F1700714 73H1700481 73J1700288 73J1700600 73M1700248 73B1800122 73B1800485 73B1800705 73D1800311 73D1800463 73E1800387 73F1800331 73G1800805 73H1800667 73J1800324  f) REF 5-10409 Batch numbers: 73K1600726 73L1600847 73A1700098 73A1700262 73C1700233 73C1700685 73D1700410 73E1700227 73F1700154 73F1700715 73H1700324 73J1700129 73J1700289 73K1700062 73K1700730 73M1700140 73A1800058 73B1800329 73B1800486 73B1800706 73C1800480 73D1800312 73E1800059 73E1800554 73F1800169  g) REF 5-10410 Batch numbers: 73K1600579 73L1600146 73L1600848 73A1700099 73B1700145 73B1700389 73C1700234 73C1700686 73D1700411 73E1700470 73F1700155 73F1700384 73F1700716 73H1700325 73J1700130 73K1700063 73K1700731 73M1700141 73B1800346 73B1800707 73C1800481 73E1800230 73E1800791 73F1800543  h) REF 5-10411 Batch numbers: 73J1600685 73K1600580 73L1600849 73A1700263 73C1700235 73C1700687 73D1700623 73E1700471 73F1700156 73F1700717 73G1700420 73H1700326 73J1700131 73K1700064 73K1700732 73L1700319 73M1700249 73A1800059 73B1800347 73B1800708 73D1800633 73E1800388 73F1800170 73G1800223 73G1800922 73H1800730  i) REF 5-10412 Batch numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923  j) REF 5-10413 Batch numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924  k) REF 5-10414 Batch numbers: 73A1700100 73F1700064 73L1800406   
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 2		 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 170740 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.
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