Teleflex Incorporated Announces Worldwide Recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
WAYNE, Pa.–(BUSINESS WIRE)–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://impremedia-network.go-vip.net/wp-content/uploads/sites/5/2016/03/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.
Contacts
Teleflex Incorporated
Jake Elguicze
Treasurer and Vice
President, Investor Relations
610-948-2836
