Teleflex Incorporated Announces Worldwide Recall of ARROW® International Intra-Aortic Balloon Catheter Kits & Percutaneous I...
March 11 2016 - 6:30AM
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://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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160311005081/en/
Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
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