This article was originally published in The Gray Sheet
Sterilization firm Steris has submitted a 510(k) for a modified version of its System 1 liquid chemical sterilization system, company says Jan. 20. FDA cited Steris in a May 15, 2008, warning letter for selling a modified version of System 1 without appropriate 510(k) clearance. The original system was cleared in 1989, but Steris later modified the product, including changing the pump, connector design and software, FDA said. Steris will continue supporting the System 1 installed base by providing accessories, service and parts for at least two years
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Stryker recall: Firm recalls 23 Navigation System II operating room surgical navigation systems with a faulty component that may result in the screen freezing, or the system updating at a slow rate or not responding at all, Stryker and FDA announced in November communications about the Class I recall. Navigation System II is a computer-aided surgery platform used in hip, knee, spine, neurological and ear, nose and throat procedures. Hospitals were advised to stop using the product, which Stryker is arranging to have repaired. All domestic units have been fixed, and there have been no reported injuries, the firm notes
While good clinical practice inspectors in the UK and the US collaborate on matters of common interest, they say that mutual recognition is simply not possible.
Last year, Mallinckrodt attempted restructuring the firm to evade bankruptcy fears. However, the company is now filing for bankruptcy for its US generics business to address “unmanageable liabilities.”