TFX Teleflex Inc

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      

MaterialNumber

      Batch      

MaterialNumber

      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.

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Teleflex IncorporatedJake ElguiczeTreasurer and Vice President, Investor Relations610-948-2836