Teleflex Incorporated Announces Global Recall of Rüsch Endotracheal Tubes
21 Junho 2023 - 6:00PM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies for critical care and surgery, has announced a
global recall of affected batches of the below-mentioned Rüsch
Endotracheal Tube products. The Rüsch Endotracheal Tube devices are
indicated for oral or nasal intubation for airway management via
insertion into a patient’s tracheal via nose or mouth. Stylets are
used to aid insertion of endotracheal tubes into the trachea.
The products involved in the recall are as
follows. Additional detail about how to identify the affected
products is available in the recall letter.
Type of Action |
Recall Notice |
Teleflex Reference |
EIF-000537 |
Product Code & Batch/Lot Number |
Refer to Appendix 2 of the recall notice |
Commercial Name |
TOP Endotracheal tube with Cuff |
RUSCHELIT® Preformed Nasal Tracheal Tube, Two Eyes without
Cuff |
Slick Set ® Cuffed Endotracheal Tube and Stylet Set,
oral/nasal |
RUSCHELIT® Safety Clear Tracheal Tube, oral/nasal |
Slick Set ® Uncuffed Endotracheal Tube and Stylet Set,
oral/nasal |
Safety Clear Tracheal tube (without Cuff) |
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal |
RUSCHELIT® Preformed Oral Tracheal Tube, Cuffed, Oral, Murphy
Eye |
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set,
oral/nasal |
AGT Orotracheal tube |
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy |
RUSCHELIT® Preformed Nasal Tracheal Tube, Cuffed, Nasal, Murphy
Eye |
Preformed AGT Nasal Endotracheal Tube uncuffed/plain - Murphy |
AGT Nasotracheal tube |
Endotracheal Tube oral/nasal uncuffed/plain - Murphy |
RUSCHELIT® Safety Clear Plus Tracheal Tube, oral/nasal, Cuffed |
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low
Pressure Cuff |
RUSCHELIT® Super Safety Clear Microlaryngeal Tube, oral/nasal |
Preformed AGT Nasal Endotracheal Tube Murphy Eye, High Volume, Low
Pressure Cuff |
RUSCHELIT® Super Safety Clear Tracheal Tube, oral/nasal,
Cuffed |
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure
Cuff |
Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and
Insertion Aid |
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure
Cuff |
RUSCHELIT ® Safety Clear Tracheal Tube, oral/nasal, Murphy |
RUSCHELIT ® Safety Clear Tracheal Tube, oral/nasal, Magill |
Super Safety Clear Tracheal tube |
RUSCHELIT® Preformed Oral Tracheal Tube, Two Eyes without Cuff |
ENDOSOFT Tracheal tube |
Endotracheal Tube oral/nasal uncuffed/plain – Magill |
RUSCHELIT® Edgar Tube (no cuff) |
RUSCHELIT® Edgar Tube (cuffed) |
|
Note: This recall is for specific lots / batches of the above
product codes manufactured prior to April 24th, 2023 |
Teleflex commenced this voluntary Field Safety
Corrective Action on May 23, 2023 due to reports of disconnection
of the 15mm connector from the endotracheal tube (ET tube) for the
affected products. There is the possibility of oxygen desaturation
and in that event any immediate or long-term health consequences
are dependent on the degree and duration of desaturation. All
batches of Rüsch Endotracheal Tubes as listed in table above,
manufactured between JAN2018 to 24APR2023 are subject to this
recall. Reference Appendix 2 of the recall letter for a full list
of affected lots / batches.
Where patients are undergoing mechanical
ventilation in either the operating room or critical care settings,
the ventilation devices to which the affected products are
connected are designed to alarm immediately upon a disconnection in
the breathing circuit, alerting the clinician to reattach the
connector. Additional standards of care such as pulse oximetry also
alert clinicians to desaturation within seconds of its occurrence,
again permitting prompt reattachment of the connector.
As of 15-June-2023, Teleflex received 189
complaints reporting connector issues for products in scope of this
field correction. Of these 189 complaints, 11 reported injury,
including nine reports of patient desaturation, and four reports of
patient death. Three complaints reported that the patient deaths
were unrelated to the disconnection of the device and one complaint
reported that it was impossible to determine whether the device
contributed to the patient death.
The initial investigation has identified that the disconnection
results from intermittent cross-contamination of the 15mm connector
with trace amounts of silicone oil. Although this does increase the
lubricity of the connection, this does not present additional
clinical risks.
For product in situ, Teleflex advises clinical staff to ensure
the 15 mm connector is seated firmly in the ET tube to prevent
disconnection during use per the product instructions for use.
Should disconnection occur, reconnect the two components promptly
and securely in the manner described in the product instructions
for use. Clinical staff may wish to consider replacing the device,
making sure to evaluate on a case by case basis the risks
associated with extubation and reintubation.
The recall notice, with a list of affected product codes and lot
numbers, can be found through the following link:
https://teleflex.widen.net/s/dc5gwfhkzh/eif-000537-fsn-online
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®, 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,
Arrow-Trerotola, Deknatel, LMA, Pilling, PTD, QuikClot, Rüsch,
UroLift and Weck are trademarks or registered trademarks of
Teleflex Incorporated or its affiliates, in the U.S. and/or other
countries.
Source: Teleflex Incorporated:
Lawrence KeuschVice President, Investor Relations and Strategy
Development
investors.teleflex.com610-948-2836
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