FDA-Device2021-04-14Class II
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
Integra LifeSciences Corp.
Hazard
Incorrect labeling, Catheter did not have the required holes and markings
Sold states
CA CO FL KY MD NC NC NY NY TX WI
Affected count
49 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2021Don't want to check this manually?
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