Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter
November 03 2022 - 6:30AM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies for critical care and surgery, has announced a
worldwide recall of affected lots of the below-referenced Gibeck®
Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a
bacterial and viral filter, intended for connection to respiratory
equipment in intensive care units and operating theatres to protect
the equipment from potential airborne contaminants.
If the filter splits or detaches during use, the
functionality and efficiency of the device may be compromised,
potentially resulting in a leakage and insufficient air supply to
the patient with potential desaturation.
The products involved in the recall are listed
below. Additional detail about how to identify the affected
products is available in the recall letter.
Product Codes |
Commercial Name |
19012 |
Iso-Gard® Filter S with Expandi-Flex/Elbow |
19012T |
Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap |
191667-000100 |
Filter + Catheter Mount |
19211; 19212 |
Iso-Gard® Filter S |
19261; 19272 |
Iso-Gard® Filter S with Expandi-Flex |
19261T; 19262T; 19272T |
Iso-Gard® Filter S with Expandi-Flex, Tethered Cap |
19211T; 19212T |
Iso-Gard® Filter S, Tethered Cap |
Note: This recall is for specific lots of the
above-referenced product codes. Reference appendix 2 of the recall
letter for a full list of affected lots. |
Teleflex initiated this voluntary recall on
August 29, 2022 due to reports received indicating that the device
split or detached during use. Teleflex is currently issuing an
expansion to this recall to include additional lots. Select lots of
the device manufactured between December 17, 2019 and March 26,
2022 are subject to this recall and its expansion. Teleflex
requests that users immediately check their inventory for product
within the scope of this recall. Users should immediately
quarantine affected product, cease use and distribution, and follow
further instructions outlined in the recall letter. Reference
appendix 2 of the recall letter for a full list of affected
lots.
As of October 6, 2022, a total of 38 complaints
reporting the filter splitting or detaching have been received for
the products in scope of this recall. Of these 38 complaints, 4
complaints reported injuries, including patient desaturation. No
deaths or long-term patient injuries have been reported at this
time.
On October 14, 2022, the U.S. Food and Drug
Administration (FDA) classified the recall of Gibeck® Iso-Gard®
Filters 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.”
Those who have affected product should immediately identify all
patients that are currently exposed to use of this product,
discontinue use, and return all affected product to Teleflex. The
recall letter, with a full list of affected product codes and lot
numbers, can be found at the following link:
https://teleflex.widen.net/s/8qdzbmsdnm/fsn---eif-000513-01---recall-letter
Any person with questions may contact the
company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday,
or email recalls@teleflex.com.
Adverse reactions or quality problems
experienced with the use of this product should be reported to
Teleflex Customer Service using the contact information above or
may also be reported to the FDA’s MedWatch Adverse Event Reporting
program either online, by regular mail or by fax. To report to
FDA’s MedWatch Adverse Event Reporting program, complete and submit
the report Online:
www.fda.gov/medwatch/report.htm, or via 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.
About Teleflex
IncorporatedTeleflex 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 access, interventional cardiology and
radiology, anesthesia, emergency medicine, surgical, urology 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®, LMA®,
Pilling®, QuikClot®, Rüsch®, UroLift®, and Weck® – trusted
brands united by a common sense of purpose.
Forward-Looking StatementsAny
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, the Teleflex logo, Arrow, Deknatel,
Gibeck, Iso-Gard, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck
are trademarks or registered trademarks of Teleflex Incorporated or
its affiliates, in the U.S. and/or other countries.© 2022 Teleflex
Incorporated. All rights reserved.
Contacts: Teleflex Incorporated:Lawrence
KeuschVice President, Investor Relations and Strategy
Development
John Hsu, CFAVice President, Investor
Relationsinvestors.teleflex.com 610-948-2836
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