FDA recall Z-1354-2021

Product

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

Reason for recall

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

Distribution

CA CO FL KY MD NC NC NY NY TX WI

Key facts

Status

Terminated

Initiation date

2021-03-17

Report date

2021-04-14

Termination date

2021-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2021