The FDA is warning U.S. users to stop using specified lots of Intersurgical's 22mm Smoothbore breathing tubes and systems because a connector can detach and interrupt ventilation.
The agency's Nov. 10 early alert says affected stock should be quarantined and returned to Intersurgical. The company notified customers on Nov. 3.
Intersurgical traced the problem to too little solvent used to bond soft connectors to the tubing. A disconnection can reduce or stop ventilation, potentially causing organ failure, brain damage or death from insufficient oxygen. The company reported no serious injuries or deaths associated with the issue as of Nov. 3, according to the FDA.
The U.S. notice lists 11 product references, including heated-wire and bilevel breathing systems. For example, reference 5018000 is affected in lot 32511811, while reference 5025000 is affected in lot 32522651. Match both the reference and lot against the FDA's complete table.
Health Canada published a related recall on Nov. 6, identifying the same bonding problem. Its affected-product table differs from the U.S. list. Canada's notice includes reference 5183000 in lot 32517823, for example, while the FDA lists that reference in lot 32527207. The Canadian table does not establish which U.S. stock is affected.
The FDA directs distributors to notify customers and facilities to share the notice with users. U.S. customers can contact Intersurgical at 800-828-9633 or [email protected].
