Integra LifeSciences Recalls CODMAN HAKIM BACTISEAL Shunt Catheters Due to Labeling Error
Integra LifeSciences is recalling 49 units of CODMAN HAKIM BACTISEAL Shunt System catheters because they lacked required drainage holes and markings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling defect (missing holes/markings) without reported injuries, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Integra LifeSciences Corp. is recalling 49 units of the CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm. The specific product is identified by Catalog Number NS5524 and Lot Number 5028205. The recall is due to incorrect labeling; the catheters did not have the required drainage holes and markings.
The affected units were distributed to facilities in California, Colorado, Florida, Kentucky, Maryland, North Carolina, New York, Texas, and Wisconsin. The product is intended for use in the treatment of hydrocephalus.
Healthcare providers and patients should stop using the affected catheters and contact Integra LifeSciences Corp. for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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
- Integra LifeSciences Corp.
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205
Distribution
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