Teleflex Iso-Gard Filter S Lawsuits
The United States Food and Drug Administration has issued a Class I Recall notice for Teleflex Iso-Gard Filter S medical devices. A Class I Recall is the most severe type of product recall. The use of these recalled devices may cause serious injuries or death. The U.S. health regulator’s recall notice states that this medical device, which is used to protect patients from airborne contaminants, has a dangerous issue that could lead to injuries or fatalities. Teleflex previously recalled certain models of the filter back in August after it received reports of the devices splitting and becoming detached from patients’ respiratory devices while in use. When the medical device is detached or split, it could cause an insufficient supply of air for patients and cause cross-contamination. So far, there have been 2.7 million filters recalled. These units were distributed between September 1, 2020, through July 5, 2022.
There have been more than 35 complaints, four injury reports, and no reports of fatalities or long-term injuries connected with the use of this recalled medical device, the U.S. Food and Drug Administration said. The total number of recalled devices is 60,000.
Iso-Gard Filter S filters are breathing filters that screen out bacteria, and they are connected to breathing systems or respiratory equipment in operating rooms and in intensive care units. The recalled filters are used to protect the equipment and the patients from airborne contaminants.
Reason for the Recall
Teleflex recalled various types of the ISO-Gard Filter S after the company received several reports that the filters may split or detach from respiratory systems. Should the filter split or detach while in use, the filter may cause the patient’s oxygen levels to fall below safe levels or cross-contaminate, causing serious injury or death.
People who use Iso-Gard Filter S in breathing systems that use the Iso-Gard Filter S are affected by the recall. Moreover, health care personnel who provide care for patients on breathing systems that use the Iso-Gard Filter S.
Teleflex has already sent customers a Medical Device Recall letter. This warning letter also recommended the following actions:
For medical facilities:
- Immediately inspect inventory for the recalled products.
- Stop using the affected products.
- Quarantine any recalled products.
- Fill out the Acknowledgement Form that is provided with the letter.
- Clients who have the affected products must:
- Mark the checkbox on the Acknowledgement Form.
- Contact Teleflex Customer Service.
- Add the return goods authorization (RGA) number that is provided by customer service on the Acknowledgement Form
- Email the completed form to Teleflex Customer Service.
- Customers who do not have the impacted product:
- Check off the applicable checkbox on the Acknowledgement Form
- Send the form to Teleflex.
For distributors:
- Issue a recall notice to all customers who have the recalled product.
- Ask each customer to complete the Acknowledgement Form and send it back to their distributor.
- Immediately inspect all inventory for the recalled products.
- Stop the use and distribution of the recalled products.
- Quarantine all recalled products.
- Return the products.
- Distributors must confirm to Teleflex the activities, as outlined in the recall letter, were been completed.
- Return the Acknowledgement Form to Teleflex Customer Service and only list the batch numbers.
- Contact Teleflex if products were distributed outside of the United States.
Doctors and patients may report adverse reactions or problems experienced while using these devices to the FDA’s MedWatch program.
If you or a loved one have been harmed by a Teleflex Iso-Gard Filter S, you or your loved one may be qualified to file a lawsuit seeking substantial economic compensation.
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