FDA designates Class 1 recalls for craniotomy kit, surgical applicator, ventilators

Editor's Note

The US Food and Drug Administration (FDA) has deemed Medline’s recent Craniotomy Kit recall, Integra LifeSciences’ MicroMyst Applicator recall, and Maquet Critical Care’s recent ventilator recall as Class I, the most severe category indicating serious risk of injury or death.

As detailed in a July 22 FDA announcement, the Medline recall involves certain lots of Craniotomy Kits containing recalled Codman Disposable Perforators 14mm, which were recalled due to an inadequate weld. Risks include dura, contusion, bleeding, irreversible brain damage, and death. No injuries or deaths have been reported so far. As detailed in the full announcement, users are advised to check stock and quarantine all affected product.

Affected product should be quarantined and the manufacturer notified. The FDA’s July 22 announcement offers full instruction for customers as well as distributors and sales representatives.

A separate July 22 FDA report details risks of inaccurate compliance measurement with the Servo-u, Servo-n, and Servo-u MR devices. Improper tidal volume delivery in neonatal patients could potentially result in hypoventilation and hypoxia as well as hypercapnia in extremely premature neonates. The full announcement offers additional details, as well as instructions for users. One injury has been reported.