(Reuters) – ResMed said its respiratory masks containing magnets will remain on the market even though the U.S. Food and Drug Administration classified a recall of the product as most serious as their use could cause major injuries or death.
The California-based medical device maker, which started the recall process on Nov. 20, said the classification was due to a correction in the labeling and is not a product removal.
The FDA defines a recall as a method of removing or correcting products that are in violation of laws administered by the health regulator and does not include a market withdrawal.
ResMed’s masks are safe to be used when kept at a distance of at least 6 inches away from implants or medical devices that may be adversely affected by magnetic interference, according to the company’s website.
The company said people with close physical contact to or patients who have active medical implants that interact with magnets such as pacemakers, implantable cardioverter defibrillators (ICD) or with metallic implants like aneurysm clips and stents should not use the mask.
(Reporting by Sriparna Roy in Bengaluru; Editing by Krishna Chandra Eluri)
Comments