FDA Class I Recall: Teleflex Iso-Gard Filter S

Nov. 3, 2022

Teleflex has recalled its Iso-Gard Filter S for the potential risk of splitting or detaching, which may cause leakage and insufficient air supply to patients.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Product Name: Iso-Gard Filter S 
  • Product Models: see recall database entries
  • Distribution Dates: September 1, 2020 to July 5, 2022
  • Devices Recalled in the U.S.: 60,500
  • Date Initiated by Firm: August 26, 2022

Device Use

Iso-Gard Filter S filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in intensive care units and operating rooms. These filters protect the equipment and the patients from potential airborne contaminants. 

Reason for Recall 

Teleflex is recalling several types of the ISO-Gard Filter S after receiving reports that the filters may split or detach from breathing systems. If the filter splits or detaches during use, the filter may not work properly or efficiently. The issue may cause a patient to receive an insufficient supply of air and for the patient’s oxygen levels to drop below safe levels (desaturation), as well as potential cross-contamination.  

Use of these devices may cause serious injury or death. 

Teleflex reported that there have been 36 complaints and 4 injuries, including desaturation, related to this issue. There have been no reports of deaths or long-term injuries. 

Who May be Affected 

  • People who receive care from breathing systems that use the Iso-Gard Filter S.
  • Health care personnel providing care for patients with breathing systems that use the Iso-Gard Filter S. 

What to Do 

On August 26, 2022, Teleflex sent customers an Urgent Medical Device Recall letter. The letter recommended the following actions: 

For medical facilities

  • Immediately check inventory for products within the recall scope.
  • Stop using and distributing affected products.
  • Quarantine any affected products.
  • Complete the Acknowledgement Form provided with the letter.
    • Customers with impacted product:
      • Mark the applicable checkbox on the Acknowledgement Form.
      • Contact Teleflex Customer Service.
      • Write the return goods authorization (RGA) number provided by customer service on the Acknowledgement Form
      • Promptly return this form by email to Teleflex Customer Service.
    • Customers without impacted product:
      • Mark the applicable checkbox on the Acknowledgement Form
      • Return the form to Teleflex at the contact details provided.
  • Teleflex (or local dealers) will issue credit notes after receiving returned affected products.

For distributors

  • Provide the recall notice to all customers who have received impacted product. 
  • Have each customer complete the Acknowledgement Form and return it to their distributor.
  • Immediately check inventory for impacted products. 
  • Cease use and distribution of impacted products.
  • Quarantine the affected products. 
  • Return all product in scope.
  • Distributors are required to confirm to Teleflex the activities outlined in the letter have been completed. 
  • Return the completed Acknowledgement Form to Teleflex Customer Service after completing the steps above. List only batch numbers in scope of the recall notice. 
  • Notify Teleflex if products were further distributed beyond the United States.

FDA release

Photo 198602321 | Healthcare © Nastassia Samal | Dreamstime.com
Illustration 95879673 © Sandamali Fernando | Dreamstime.com
Photo 202771086 © Kapil Joshi | Dreamstime.com
Photo 159538255 © Thanee Hengpattanapong | Dreamstime.com
Photo 144935703 © Andrey Metelev | Dreamstime.com