FDAClass IIApril 14, 2021

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium recall: Labeling Error

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

Why was CODMAN HAKIM BACTISEAL Shunt System Clear with Barium recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of…
Recalling firm
Integra LifeSciences Corp.
Quantity
49 units
Distribution
CA CO FL KY MD NC NC NY NY TX WI
Recall date
April 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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