Teleflex Incorporated Announces Worldwide Voluntary Recall of HUDSON RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube

Teleflex Incorporated

announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall of HUDSON RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube as a Class 1 recall. FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." Teleflex is recalling the products referenced above following receipt of customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. Should this occur, the device may leak, causing a risk of respiratory distress or hypoxia that can, in some cases, lead to the need to re-intubate the patient. There have been no reports of patient injury as a result of this issue. Teleflex notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated June 1, 2015. This recall involves the retrieval of unused product in the field. At the time of the recall, there were 78 complaints of this issue. Two-hundred thirty-three (233) lots across twelve (12) product codes are affected by this recall for a total of 188,195 units distributed to the field. See table below for affected product codes. A full list of affected lot numbers can be found in the appendix to this notification. PRODUCTS AFFECTED: Product Codes 5-15401 5-16037 5-16128 5-16139 5-16028 5-16039 5-16135 5-16141 5-16035 5-16041 5-16137 5-16142 The original recall notice can be found at Teleflex's website: http://www.teleflex.com/en/recall/Sheribronch%201st%20Customer%20Notification.pdf Consumers with questions may contact the company at 1-866-246-6990; 8am to 8pm, ET, Monday through Friday. Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. Appendix Material Number Batch Material Number Batch Material Number Batch 5-15401 01K1300254 5-16037 01K1300143 5-16039 73E1400114 01L1300393 01K1300144 73F1400353 01M1300212 01K1300346 73G1400256 01A1400436 01K1300347 73G1400377 01C1400086 01K1300579 73J1400398 73D1400096 01L1300081 73J1400408 73D1400496 01L1300280 73K1400463 73E1400269 01L1300281 73L1400196 73F1400153 01L1300384 73L1400097 73F1400352 01L1300558 73M1400194 73G1400052 01M1300074 73A1500483 73G1400288 01M1300117 73A1500484 73H1400331 01M1300213 73A1500591 73J1400401 01M1300313 73A1500592 73L1400106 01A1400121 73C1500112 73M1400208 01A1400194 73C1500113 73A1500345 01A1400433 73C1500258 73B1500272 01A1400575 73C1500259 73C1500255 01B1400084 01L1300385 5-16028 01L1300279 01B1400115 01A1400122 01A1400574 01B1400242 01C1400261 73D1400255 01C1400087 73E1400115 73F1400448 01C1400088 73G1400388 73J1400537 01C1400285 73J1400399 73A1500341 73D1400256 73A1500204 73C1500431 73D1400627 73B1500533 5-16035 01J1300471 73E1400270 73C1500583 01J1300472 73E1400366 01L1300155 01K1300050 73F1400189 01A1400453 01K1300073 73G1400053 5-16041 73L1400096 01K1300578 73G1400176 73B1500256 01L1300382 73H1400034 01C1400406 01L1300383 73H1400161 73D1400497 01L1300557 73H1400333 73F1400095 01M1300073 73H1400442 73J1400116 01M1300312 73J1400538 73J1400133 01A1400226 73J1400547 73K1400464 01A1400432 73K1400341 73K1400465 01B1400083 73K1400342 5-16128 73L1400012 01B1400356 73K1400343 73K1400582 01B1400357 73K1400462 73L1400233 01C1400260 73L1400098 73A1500039 73D1400097 73L1400234 5-16135 73A1500040 73E1400504 73L1400235 73B1500259 73F1400449 73L1400584 73B1500293 73G1400387 73L1400609 73C1500401 73G1400597 73M1400071 73C1500426 73H1400033 73M1400072 01K1300470 73H1400332 73M1400073 01B1400479 73J1400259 73M1400192 73D1400498 73J1400260 73M1400193 73F1400096 73J1400261 73A1500342 73H1400443 73K1400130 73A1500343 73J1400117 73K1400131 73A1500344 73K1400583 73K1400132 73A1500590 73L1400094 73K1400225 73A1500589 73A1500205 73K1400226 73B1500076 73A1500206 73K1400227 73B1500532 73B1500258 73L1400236 73C1500110 5-16137 73B1500354 73L1400382 73C1500111 73B1500355 73L1400383 73C1500531 73C1500402 73L1400384 73C1500532 73C1500427 73L1400489 73C1500582 5-16139 73G1400177 73L1400583 73D1500096 73H1400444 73L1400608 73D1500097 73L1400095 73A1500481 73D1500098 73A1500041 73A1500482 5-16039 01K1300469 73A1500203 73B1500077 01L1300082 5-16141 01L1300156 73B1500078 01L1300083 01A1400452 73B1500353 01L1300559 73G1400178 73B1500529 01M1300214 73G1400510 73B1500530 01A1400227 73H1400009 73B1500531 01A1400576 73K1400553 73C1500256 01B1400243 73B1500257 73C1500257 01B1400478 5-16142 01J1300535 73C1500581 73C1400067 01M1300215 73D1500099 73D1400340 01A1400321 73D1400579 73E1400113