COMPANY ANNOUNCEMENT
Teleflex Incorporated Announces Worldwide Voluntary Recall of Select Hudson RCI® Sheridan® Endotracheal Tubes
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
General Hospital & Personal Use - Reason for Announcement:
-
Recall Reason DescriptionThe connector could disconnect from the endotracheal tube, resulting in insufficient oxygenation of the patient
- Company Name:
- Teleflex Incorporated
- Brand Name:
-
Brand Name(s)Hudson RCl Sheridan
- Product Description:
-
Product DescriptionHudson RCl Sheridan Endotracheal Tubes
Company Announcement
Teleflex Incorporated (NYSE: TFX), has announced a worldwide recall of certain lots of Hudson RCI@ Sheridan@ Endotracheal Tubes. The recalled products are designed for oral or nasal intubation and are indicated for airway management. The products involved in this recall are as follows:
| Product Name | Product Code |
Product Name | Product Code |
|---|---|---|---|
| Hudson RCI@ Sheridan LTS@ | 5-11112 | Hudson RCI@ Sheridan@ Preformed 7.0 mm | 5-22214 |
| Hudson RCI@ Sheridan/CF@ 6.0 mm | 5-10112 | 5-22314 | |
| 5-10212 | 5-22014 | ||
| Hudson RCI@ Sheridan/CF@ 6.5 mm | 5-10113 | 5-22114 | |
| 5-10213 | Hudson RCI@ Sheridan@ Preformed 7.5 mm | 5-22215 | |
| Hudson RCI@ Sheridan/CF@ 7.0 mm | 5-10114 | 5-22315 | |
| 5-10214 | Hudson RCI@ Sheridan@ Preformed 8.0 mm | 5-22216 | |
| Hudson RCI@ Sheridan/CF@ 7.5 mm | 10115 | 5-22316 | |
| 5-10115 | Hudson RCI@ Sheridan@ Preformed 8.5 mm | 5-22217 | |
| 5-10215 | Hudson RCI@ Sheridan@ Uncuffed 6.0 mm | 5-10412 | |
| Hudson RCI@ Sheridan/CF@ 8.0 mm | 5-10116 | Hudson RCI@ Sheridan@ Uncuffed 6.5 mm | 5-10413 |
| 5-10216 | Hudson RCI@ Sheridan@ Uncuffed 7.0 mm | 5-10414 | |
| 10116 | Hudson RCI@ Sheridan@/EZ-ENDO 6.0 mm | 5-22512 | |
| Hudson RCI@ Sheridan/CF@ 8.5 mm | 5-10117 | Hudson RCI@ Sheridan@/EZ-ENDO 6.5 mm | 5-22513 |
| 5-10217 | Hudson RCI@ & 6.0 mm | 5-10312 | |
| Hudson RCI@ Sheridan EZ-ENDO 7.0 mm | 5-22514 | Hudson RCI@ 6.5 mm | 5-10313 |
| Hudson RCI@ Sheridan EZ-ENDO 7.5 mm | 5-22515 | Hudson RCI@ 7.0 mm | 5-10314 |
| Hudson RCI@ Sheridan EZ-ENDO 8.0 mm | 5-22516 | Hudson RCI@ 7.5 mm | 5-10315 |
| Hudson RCI@ Sheridan EZ-ENDO 8.5 mm | 5-22517 | Hudson RCI@ 8.0 mm | 5-10316 |
| Hudson RCI@ Sheridan@ Preformed 6.0 mm | 5-22212 | Hudson RCI@ 8.5 mm | 5-10317 |
| 5-22312 | Sheridan/CF Novaplus@ 7.0 mm | V5-10114 | |
| 5-22112 | Sheridan/HVT@ Novaplus@ 7.0 mm | V5-10314 | |
| 5-22012 | Sheridan/HVT@ Novaplus@ 7.5 mm | V5-10315 | |
| Hudson RCI@ Sheridan@ Preformed 6.5 mm | 5-22313 | Sheridan/HVT@ Novaplus@ 8.0 mm | V5-10316 |
| 5-22213 | Sheridan/HVT@ Novaplus@ 8.5 mm | V5-10317 | |
| 5-22013 | |||
| 5-22113 | |||
These recalled products were distributed from October 2016 to May 2019. Specific lot codes may be found through the following link: https://p.widencdn.net/ivsxip/AN_ETT_Connector_Customer_Recall_Letter
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). The immediate consequence for patients is disconnection from the breathing circuit, which may result in insufficient oxygenation, requiring medical intervention. There have been four reports of death, and additional reports of serious injury where ETT disconnection may have been a factor.
The U.S. Food and Drug Administration (FDA) has classified the recall of Hudson RCI® Sheridan® Endotracheal Tubes 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 or its distributor. The recall notice, with a list of affected product codes and lot numbers, 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
- Regular Mail or Fax: Download form 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®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift®, and Weck® – trusted brands united by a common sense of purpose.
Forward-Looking Statements
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, 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.
Company Contact Information
- Consumers:
- 1-866-396-2111
- recalls@teleflex.com
- Media:
- Jake Elguicze, Treasurer and Vice President, Investor Relations
- 610-948-2836