Recall Z-2136-2024— Integra LifeSciences Corp.

Name: FDA recall Z-2136-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-07

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-05-07. It names one FDA 510(k) clearance: K233448. Product: CODMAN BACTISEAL EVD 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: 821745. Reason: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-05-07
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation·cleared 2023-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CODMAN BACTISEAL EVD 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: 821745

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.