- Company Announcement Date:
- November 03, 2022
- FDA Publish Date:
- November 04, 2022
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason Description
Bacterial and viral filters
- Company Name:
- Teleflex Incorporated
- Brand Name:
Gibeck® and Iso-Gard®
- Product Description:
Bacterial and viral filters
WAYNE, Pa., Nov. 03, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for connection to respiratory equipment in intensive care units and operating theatres to protect the equipment from potential airborne contaminants.
If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation.
The products involved in the recall are listed below. Additional detail about how to identify the affected products is available in the recall letter.
|Product Codes||Commercial Name|
|19012||Iso-Gard® Filter S with Expandi-Flex/Elbow|
|19012T||Iso-Gard® Filter S with Expandi-Flex/Elbow, Tethered Cap|
|191667-000100||Filter + Catheter Mount|
|19211; 19212||Iso-Gard® Filter S|
|19261; 19272||Iso-Gard® Filter S with Expandi-Flex|
|19261T; 19262T; 19272T||Iso-Gard® Filter S with Expandi-Flex, Tethered Cap|
|19211T; 19212T||Iso-Gard® Filter S, Tethered Cap|
|Note: This recall is for specific lots of the above-referenced product codes. Reference appendix 2 of the recall letter for a full list of affected lots.|
Teleflex initiated this voluntary recall on August 29, 2022 due to reports received indicating that the device split or detached during use. Teleflex is currently issuing an expansion to this recall to include additional lots. Select lots of the device manufactured between December 17, 2019 and March 26, 2022 are subject to this recall and its expansion. Teleflex requests that users immediately check their inventory for product within the scope of this recall. Users should immediately quarantine affected product, cease use and distribution, and follow further instructions outlined in the recall letter. Reference appendix 2 of the recall letter for a full list of affected lots.
As of October 6, 2022, a total of 38 complaints reporting the filter splitting or detaching have been received for the products in scope of this recall. Of these 38 complaints, 4 complaints reported injuries, including patient desaturation. No deaths or long-term patient injuries have been reported at this time.
On October 14, 2022, the U.S. Food and Drug Administration (FDA) classified the recall of Gibeck® Iso-Gard® Filters 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.”
Those 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 letter, with a full list of affected product codes and lot numbers, can be found at the following link: https://teleflex.widen.net/s/8qdzbmsdnm/fsn—eif-000513-01—recall-letter
Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service using the contact information above or may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. To report to FDA’s MedWatch Adverse Event Reporting program, 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, Deknatel, Gibeck, Iso-Gard, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2022 Teleflex Incorporated. All rights reserved.
Vice President, Investor Relations and Strategy Development
John Hsu, CFA
Vice President, Investor Relations