Teleflex recalls 61K breathing system filters, prompting FDA Class I designation

After receiving a few dozen reports of issues with several of its respiratory filters, Teleflex has initiated a recall of more than 61,000 of the devices.

The recall includes several models of Teleflex’s Gibeck Iso-Gard filters, spanning hundreds of lot numbers. The filters are used in intensive care units and operating rooms, where they connect to breathing systems to protect both patients and the equipment from bacterial and viral contaminants.

The recall began in late August but was expanded several weeks later to include more of the filters, “based on the outcome of further investigation,” Teleflex said in an October letter (PDF) to customers. In a safety notice of its own this month, the FDA handed down a Class I rating to the recall, denoting an increased chance of serious injury or death linked to the issue.

The recall was sparked by several reports to Teleflex of Iso-Gard filters splitting or detaching from breathing systems while in use. If that happens, not only could cross-contamination occur, but also, the company said in the October letter, “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.”

Oxygen desaturation, or hypoxia, occurs when blood oxygen levels drop below the normal range. It can lead to symptoms such as difficulty breathing, confusion, drowsiness, a rapid or abnormal heart rate and more.

As of the beginning of October, Teleflex said it had received a total of 38 complaints in which a filter had split or detached. Four of those complaints detailed patient injuries, including desaturation, though none were linked to patient deaths or long-term injuries.

In total, according to a half dozen entries in the FDA’s recall database, the safety event affects 61,080 devices distributed in the U.S. They were manufactured between December 2019 and March 2022, Teleflex said in a recall notice this month, and they were distributed up until July of this year.

With the recall in full swing, Teleflex has asked distributors to look through their existing stores of the Iso-Gard filters to find any in the affected lots, then immediately quarantine and send back those filters. They should also notify any of their healthcare facility customers who may have received the affected devices. Those healthcare providers are also asked to immediately stop using all filters that are labeled with the specified lot numbers, quarantine them and return the affected products.

All medical facilities and device distributors should confirm with Teleflex that they’ve gone through their inventories for the affected batch numbers whether or not they find any included in the recall.