Teleflex Incorporated Announces Worldwide Voluntary Recall of COMFORT FLO® Humidification System
February 14 2020 - 5:00PM
Teleflex Incorporated (NYSE: TFX), a global provider of medical
technologies for critical care and surgery, has announced a
worldwide voluntary recall of the COMFORT FLO® Humidification
System. The recalled products provide a continuous flow of
heated and humidified gas to COMFORT FLO® patients in professional
health care environments. The products involved in the recall are
as follows:
Product Name |
Product Code |
Lot Numbers |
COMFORT FLO Humidification System |
2410 |
See Appendix 1 |
COMFORT FLO Humidification System with Remote Port Extension |
2414 |
Corrugated COMFORT FLO |
2415 |
Corrugated COMFORT FLO Remote Temp Port |
2416 |
These recalled products were manufactured from
October 2014 through June 2019. Products manufactured after June
2019 are now being packaged with our new COMFORT FLO® columns for
high flow therapy. The recalled product can be identified by the
presence of only one white reservoir clamp on the feed tube
(distinguishing itself from new product which contains two blue
reservoir clamps on the feed tube). Specific lot codes may be
found through the following link:
https://p.widencdn.net/svhco2/EIF-387-Amend-Cust-letter-ack-appx
Teleflex is recalling the above product codes
and lots due to the potential for water to flood the column and
enter the circuit under circumstances where an abnormal pressure
differential is created between the water bottle and the column
during high flow oxygen therapy.
The potential health consequence of exposure to
water ingress is the aspiration of fluid into the nose and lungs
that may result in oxygen desaturation. The company has received
102 complaints of water ingress in which intervention has been
required on several patients to prevent serious injury or permanent
impairment. The Company has not received any reports of
death. In one instance, fluid aspiration and subsequent
desaturation required invasive respiratory support including
intubation and positive pressure ventilation. In another instance,
an infant in a NICU experienced aspiration with desaturation and
bradycardia requiring bag mask ventilation. Aspiration in patients
requiring supplementary oxygen to prevent hypoxemia also has the
potential to result in respiratory arrest, cardiac arrest,
permanent brain and/or cardiac injury, and death. The long-range
health consequences depend on the degree and duration of
desaturation and the rapidity and success of medical interventions
to resuscitate the patient.
The U.S. Food and Drug Administration (FDA) has
classified the recall of the COMFORT FLO® Humidification System 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 identify all patients that are currently exposed to use
of this product, discontinue use, and return all affected product
to Teleflex. The recall notice, with a list of affected product
codes and lot numbers, can be found through the following link:
https://p.widencdn.net/svhco2/EIF-387-Amend-Cust-letter-ack-appx
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 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 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, Rusch, and Weck are trademarks or registered trademarks of
Teleflex Incorporated or its affiliates, in the U.S. and/or other
countries. © 2020 Teleflex Incorporated. All rights reserved.
MC-XXXXXX
Source: Teleflex IncorporatedJake
ElguiczeTreasurer and Vice President, Investor
Relations610-948-2836
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