Teleflex Incorporated (NYSE: TFX) announces worldwide recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. The Arrow® IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.

Teleflex Incorporated announced today that the U.S. Food and Drug Administration (FDA) has classified the recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits as a Class I recall. FDA defines a Class I recall 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.”

On 9-Feb-2016, Teleflex Incorporated initiated a worldwide recall of 47,140 units distributed to hospitals, clinics, and medical centers throughout the United States and globally. The ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits are being recalled because the sheath body may become separated from the sheath hub. If the separation occurs, the patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss or exsanguination may occur. Interruption or loss of intra-aortic balloon pump treatment may also occur. At the time of the recall, there were 13 adverse events reported; including 6 serious injuries and 1 death.

Teleflex notified domestic distributors and customers via an Urgent Medical Device recall letter dated February 11, 2016. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.

Teleflex has notified the FDA of this action.

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 Code       Lot   IAB-05830-LWS       Reference Appendix   IAB-05830-U   IAB-05840-LWS   IAB-05840-U   IAB-06830-U   IAB-06840-U   IAB-S730C   IAK-06845   IAK-S7IT        

The original recall notice can be found at Teleflex’s website: http://www.teleflex.com/en/recall/Customer_letter_and_form_press_release.pdf

Consumers with questions may contact the company at 1-866-246-6990; 8am to 8pm, ET, Monday through Friday or at recalls@teleflex.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
      Product Code   Lot IAB-05830-LWS   18F14A0031 IAB-05830-LWS   18F14A0032 IAB-05830-LWS   18F14A0033 IAB-05830-LWS   18F14D0066 IAB-05830-LWS   18F14E0018 IAB-05830-LWS   18F14E0072 IAB-05830-LWS   18F14F0067 IAB-05830-LWS   18F14F0079 IAB-05830-LWS   18F14G0045 IAB-05830-LWS   18F14G0046 IAB-05830-LWS   18F14G0081 IAB-05830-LWS   18F14H0037 IAB-05830-LWS   18F14J0023 IAB-05830-LWS   18F14L0014 IAB-05830-LWS   18F14M0033 IAB-05830-LWS   18F15A0010 IAB-05830-LWS   18F15B0015 IAB-05830-LWS   18F15C0004 IAB-05830-LWS   18F15C0023 IAB-05830-LWS   18F15D0025 IAB-05830-LWS   18F15D0052 IAB-05830-LWS   18F15E0020 IAB-05830-LWS   18F15F0002 IAB-05830-LWS   18F15F0039 IAB-05830-LWS   18F15G0005 IAB-05830-LWS   18F15G0015 IAB-05830-LWS   18F15H0006 IAB-05830-LWS   18F15H0037 IAB-05830-LWS   18F15H0051 IAB-05830-LWS   18F15J0026 IAB-05830-LWS   18F15L0007 IAB-05830-LWS   18S14G0046 IAB-05830-LWS   18S15A0021 IAB-05830-U   18F14E0030 IAB-05830-U   18F14H0019 IAB-05830-U   18F14J0038 IAB-05830-U   18F14K0012 IAB-05830-U   18F14K0019 IAB-05830-U   18F15D0030 IAB-05830-U   18F15E0017 IAB-05840-LWS   18F14A0025 IAB-05840-LWS   18F14A0026 IAB-05840-LWS   18F14A0030 IAB-05840-LWS   18F14A0049 IAB-05840-LWS   18F14A0050 IAB-05840-LWS   18F14A0051 IAB-05840-LWS   18F14A0054 IAB-05840-LWS   18F14A0057 IAB-05840-LWS   18F14A0066 IAB-05840-LWS   18F14A0067 IAB-05840-LWS   18F14D0045 IAB-05840-LWS   18F14E0004 IAB-05840-LWS   18F14E0006 IAB-05840-LWS   18F14E0016 IAB-05840-LWS   18F14E0017 IAB-05840-LWS   18F14E0052 IAB-05840-LWS   18F14F0017 IAB-05840-LWS   18F14F0047 IAB-05840-LWS   18F14F0049 IAB-05840-LWS   18F14F0080 IAB-05840-LWS   18F14G0003 IAB-05840-LWS   18F14G0004 IAB-05840-LWS   18F14G0021 IAB-05840-LWS   18F14G0037 IAB-05840-LWS   18F14G0055 IAB-05840-LWS   18F14G0056 IAB-05840-LWS   18F14G0068 IAB-05840-LWS   18F14G0070 IAB-05840-LWS   18F14G0071 IAB-05840-LWS   18F14G0076 IAB-05840-LWS   18F14H0009 IAB-05840-LWS   18F14H0030 IAB-05840-LWS   18F14H0054 IAB-05840-LWS   18F14H0055 IAB-05840-LWS   18F14H0060 IAB-05840-LWS   18F14H0061 IAB-05840-LWS   18F14J0003 IAB-05840-LWS   18F14J0005 IAB-05840-LWS   18F14J0037 IAB-05840-LWS   18F14K0006 IAB-05840-LWS   18F14M0001 IAB-05840-LWS   18F14M0014 IAB-05840-LWS   18F14M0032 IAB-05840-LWS   18F15A0005 IAB-05840-LWS   18F15A0011 IAB-05840-LWS   18F15A0026 IAB-05840-LWS   18F15A0034 IAB-05840-LWS   18F15B0005 IAB-05840-LWS   18F15B0008 IAB-05840-LWS   18F15B0010 IAB-05840-LWS   18F15B0018 IAB-05840-LWS   18F15B0020 IAB-05840-LWS   18F15B0027 IAB-05840-LWS   18F15C0002 IAB-05840-LWS   18F15C0007 IAB-05840-LWS   18F15C0010 IAB-05840-LWS   18F15C0015 IAB-05840-LWS   18F15C0024 IAB-05840-LWS   18F15C0030 IAB-05840-LWS   18F15C0036 IAB-05840-LWS   18F15D0017 IAB-05840-LWS   18F15D0032 IAB-05840-LWS   18F15D0034 IAB-05840-LWS   18F15D0043 IAB-05840-LWS   18F15D0049 IAB-05840-LWS   18F15E0003 IAB-05840-LWS   18F15E0011 IAB-05840-LWS   18F15E0014 IAB-05840-LWS   18F15E0023 IAB-05840-LWS   18F15E0029 IAB-05840-LWS   18F15E0037 IAB-05840-LWS   18F15F0011 IAB-05840-LWS   18F15F0017 IAB-05840-LWS   18F15F0021 IAB-05840-LWS   18F15F0032 IAB-05840-LWS   18F15G0001 IAB-05840-LWS   18F15G0013 IAB-05840-LWS   18F15G0021 IAB-05840-LWS   18F15G0028 IAB-05840-LWS   18F15G0034 IAB-05840-LWS   18F15H0010 IAB-05840-LWS   18F15H0015 IAB-05840-LWS   18F15H0021 IAB-05840-LWS   18F15H0024 IAB-05840-LWS   18F15H0033 IAB-05840-LWS   18F15J0013 IAB-05840-LWS   18F15J0028 IAB-05840-LWS   18F15J0038 IAB-05840-LWS   18F15J0044 IAB-05840-LWS   18F15J0049 IAB-05840-LWS   18F15K0001 IAB-05840-LWS   18F15K0007 IAB-05840-LWS   18F15L0002 IAB-05840-LWS   18S14G0068 IAB-05840-LWS   18S14M0001 IAB-05840-LWS   18S15C0002 IAB-05840-U   18F14B0044 IAB-05840-U   18F14B0045 IAB-05840-U   18F14E0060 IAB-05840-U   18F14F0019 IAB-05840-U   18F14G0067 IAB-05840-U   18F14H0002 IAB-05840-U   18F14J0026 IAB-05840-U   18F15A0033 IAB-05840-U   18F15B0009 IAB-05840-U   18F15B0019 IAB-05840-U   18F15C0012 IAB-05840-U   18F15D0016 IAB-05840-U   18F15D0037 IAB-05840-U   18F15D0044 IAB-05840-U   18F15F0001 IAB-06830-U   18F13M0016 IAB-06830-U   18F14A0017 IAB-06830-U   18F14A0018 IAB-06830-U   18F14A0022 IAB-06830-U   18F14A0046 IAB-06830-U   18F14E0054 IAB-06830-U   18F14E0070 IAB-06830-U   18F14G0038 IAB-06830-U   18F14G0078 IAB-06830-U   18F14H0007 IAB-06830-U   18F14J0007 IAB-06830-U   18F14J0025 IAB-06830-U   18F14K0016 IAB-06830-U   18F15A0035 IAB-06830-U   18F15B0006 IAB-06830-U   18F15B0014 IAB-06830-U   18F15C0019 IAB-06830-U   18F15E0028 IAB-06830-U   18F15F0016 IAB-06830-U   18F15G0007 IAB-06830-U   18F15H0009 IAB-06830-U   18F15H0035 IAB-06840-U   18F13M0017 IAB-06840-U   18F13M0019 IAB-06840-U   18F13M0021 IAB-06840-U   18F14A0012 IAB-06840-U   18F14A0013 IAB-06840-U   18F14A0015 IAB-06840-U   18F14A0016 IAB-06840-U   18F14A0044 IAB-06840-U   18F14A0047 IAB-06840-U   18F14B0042 IAB-06840-U   18F14B0043 IAB-06840-U   18F14D0068 IAB-06840-U   18F14E0005 IAB-06840-U   18F14E0007 IAB-06840-U   18F14E0031 IAB-06840-U   18F14E0053 IAB-06840-U   18F14E0069 IAB-06840-U   18F14F0030 IAB-06840-U   18F14F0031 IAB-06840-U   18F14F0066 IAB-06840-U   18F14G0020 IAB-06840-U   18F14G0039 IAB-06840-U   18F14G0066 IAB-06840-U   18F14H0003 IAB-06840-U   18F14H0010 IAB-06840-U   18F14H0023 IAB-06840-U   18F14H0024 IAB-06840-U   18F14H0056 IAB-06840-U   18F14J0006 IAB-06840-U   18F14J0016 IAB-06840-U   18F14J0027 IAB-06840-U   18F14J0051 IAB-06840-U   18F15A0008 IAB-06840-U   18F15A0015 IAB-06840-U   18F15A0023 IAB-06840-U   18F15B0003 IAB-06840-U   18F15B0007 IAB-06840-U   18F15B0021 IAB-06840-U   18F15C0006 IAB-06840-U   18F15C0011 IAB-06840-U   18F15C0027 IAB-06840-U   18F15D0010 IAB-06840-U   18F15D0019 IAB-06840-U   18F15D0045 IAB-06840-U   18F15E0002 IAB-06840-U   18F15E0012 IAB-06840-U   18F15F0008 IAB-06840-U   18F15F0028 IAB-06840-U   18F15F0038 IAB-06840-U   18F15F0041 IAB-06840-U   18F15G0016 IAB-06840-U   18F15G0027 IAB-06840-U   18F15H0005 IAB-06840-U   18F15H0020 IAB-06840-U   18F15H0032 IAB-06840-U   18F15H0041 IAB-06840-U   18F15J0007 IAB-06840-U   18F15J0010 IAB-06840-U   18F15J0021 IAB-06840-U   18F15J0029 IAB-06840-U   18F15J0039 IAB-06840-U   18F15J0056 IAB-06840-U   18F15K0016 IAB-06840-U   18F15K0032 IAB-06840-U   18F15L0001 IAB-06840-U   18F15L0010 IAB-S730C   18F14A0041 IAB-S730C   18F14C0003 IAB-S730C   18F14C0006 IAB-S730C   18F14C0021 IAB-S730C   18F14C0026 IAB-S730C   18F14C0027 IAB-S730C   18F14C0028 IAB-S730C   18F14E0039 IAB-S730C   18F14E0055 IAB-S730C   18F14E0058 IAB-S730C   18F14F0035 IAB-S730C   18F14F0038 IAB-S730C   18F14F0054 IAB-S730C   18F14G0057 IAB-S730C   18F14G0077 IAB-S730C   18F14H0011 IAB-S730C   18F15B0023 IAB-S730C   18F15C0001 IAB-S730C   18F15C0008 IAB-S730C   18F15C0026 IAB-S730C   18F15D0028 IAB-S730C   18F15F0027 IAB-S730C   18F15F0037 IAB-S730C   18F15G0003 IAB-S730C   18F15G0011 IAB-S730C   18F15G0032 IAB-S730C   18F15H0046 IAB-S730C   18F15M0009 IAK-06845   18F14A0037 IAK-06845   18F14B0040 IAK-06845   18F14E0027 IAK-06845   18F14F0027 IAK-06845   18F14F0028 IAK-S7IT   18F14A0028 IAK-S7IT   18F14B0008 IAK-S7IT   18F14D0003

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.

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

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