Integra LifeSciences Corp.: Medical Device Recall in 2024 - (Recall #: Z-2138-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750

Product Classification:

Class II

Date Initiated: May 7, 2024

Date Posted: June 19, 2024

Recall Number: Z-2138-2024

Event ID: 94622

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.

Status: Ongoing

Product Quantity: 59 units

Code Information:

UDI-DI: 10381780518457 Lot Numbers: 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, 7328569

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated