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

WAYNE, Pa.--()--Teleflex Incorporated (NYSE: TFX) 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
 

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch® and Weck® – trusted brands united by a common sense of purpose.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Contacts

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836

Release Summary

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

Contacts

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836