Integra LifeSciences Corp.: Medical Device Recall in 2021 - (Recall #: Z-1354-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

Product Classification:

Class II

Date Initiated: March 17, 2021

Date Posted: April 14, 2021

Recall Number: Z-1354-2021

Event ID: 87596

Reason for Recall:

Incorrect labeling, Catheter did not have the required holes and markings

Status: Terminated

Product Quantity: 49 units

Code Information:

Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205

Distribution Pattern:

CA CO FL KY MD NC NC NY NY TX WI

Voluntary or Mandated:

Voluntary: Firm initiated