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Integra LifeSciences Corp. recalls CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking.
Recalled April 14, 2021 · FDA recall Z-1354-2021 · Integra LifeSciences
Hazard
Incorrect labeling, Catheter did not have the required holes and markings · FDA Class II
Units
49 units
Sold at
CA CO FL KY MD NC NC NY NY TX WI
Description
Incorrect labeling, Catheter did not have the required holes and markings
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
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →