Teleflex Incorporated Announces Worldwide Voluntary Recall of GaleMed Corporation (third party manufacturer) Babi.Plus® 12.5...
October 07 2019 - 6:30AM
Teleflex Incorporated (NYSE: TFX), announced a recall June 14th,
2019 of certain lots of the GaleMed
(third party
manufacturer) Babi.Plus® 12.5 cm H2O Pressure Relief
Manifold. Teleflex receives the product from the manufacturer
GaleMed Corporation and is one of its distributors for this product
within the United States. GaleMed Corporation is the legal
manufacturer of these products.
The recalled products are designed for use with
humans with a body mass of less than 10 Kg requiring a pressure
limitation system to eliminate excessive pressure should an
obstruction occur between gas supply and exhalation port during
continuous gas flow therapy up to 12 liters per minute in hospital
and transport environments. The most used application of the
pressure relief manifold (PRM) is Bubble CPAP therapy. The products
involved in this recall are as follows:
Product Name |
Product Code |
Lot/Batch Number |
GaleMed Babi.Plus® 12.5 cm H2O Pressure Relief Manifold |
2691 |
180806180910181029181105 |
181204190225190327 |
This voluntary recall is due to a Medical Device Recall Notice
which Teleflex received from the GaleMed Corporation. GaleMed
advises that the Babi.Plus 12.5cm H2O Pressure Relief Manifold is
being recalled because it has been reported that the bubble
continuous positive airway pressure (BCPAP) system would not hold
pressure as the pressure relief manifold (PRM) internal mechanism
was lodged in the upper valve chamber which prevented engagement
with the valve seat. This may be easily identified by either
visually inspecting the pressure relief valve to confirm that the
valve is properly seated on the valve seat and/or performing a
pre-patient connection to the BCPAP system or performing a system
pressure test, as an affected valve will not allow the system to
pressurize.
GaleMed has received two (2) reports of device malfunction in
which the device vented gas below the stated pressure. Though
no injuries have been reported, use of an affected device with the
valve not properly seated on the valve seat could result in lower
blood oxygen levels and rebreathing of exhaled carbon dioxide.
These recalled products were distributed
from October 2018 to May 2019.
The U.S. Food and Drug Administration (FDA)
classified the original recall of the GaleMed Babi.Plus® 12.5 cm
H2O Pressure Relief Manifold 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.”
Consumers who have affected product should immediately
discontinue use and return all affected product to Teleflex. The
recall notice can be found through the following link:
https://p.widencdn.net/ivsxip/AN_ETT_Connector_Customer_Recall_Letter
Consumers 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 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, 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®, Hudson RCI®, LMA®,
Pilling®, 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, Hudson RCI, LMA,
Pilling, Rüsch, UroLift, and Weck are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries. © 2019 Teleflex Incorporated. All rights
reserved.
Source: Teleflex IncorporatedJake
ElguiczeTreasurer and Vice President, Investor
Relations610-948-2836
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