Integra LifeSciences Corp.: CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining

Hazard

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Details from the source

Reason for recall: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. Distribution: Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey Quantity: 106 units Lot/code info: UDI-DI: 10381780518440 Lot numbers: 7314912, 7320010, 7322933

UPC codes

10381780518440

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.