WAYNE, Pa., June 21, 2023 (GLOBE NEWSWIRE) -- 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|
|Product Code & Batch/Lot Number||Refer to Appendix 2 of the recall notice|
|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 firstname.lastname@example.org.
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 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 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.
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.
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.
Vice President, Investor Relations and Strategy Development