Integra LifeSciences Corp.: Device Recall

Recall Details

Recall Number

Z-2138-2024

Classification

Class II

Product Type

Device

Recalling Firm

Integra LifeSciences Corp.

Status

Ongoing

Date Initiated

05/07/2024

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

59 units

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.

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

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

Other Recalls by Integra LifeSciences Corp.

• Class II: Risk 02/06/2025
  Possibility for the obturator to break (separate).
• Class II: Risk 01/10/2025
  Potential that the induction seal is not completely sealed to the device tube packaging.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

View all recalls by Integra LifeSciences Corp. →