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

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: 59 units Lot/code info: UDI-DI: 10381780518457 Lot Numbers: 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, 7328569

UPC codes

10381780518457

Source

Official record: FDA (Device enforcement) ↗

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