Intracranial pressure monitoring kits recalled over corrosion stains on the needle
Integra LifeSciences is recalling 1,301 Codman Microsensor Basic Kits over potential corrosion stains on the surface of the 14-gauge Tuohy needle included in the kits.
What this means for you
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: Scored 2 because the record cites potential corrosion stains on a component with no stated consequence or reported harm.
Plain-English summary
The Codman Microsensor Basic Kit, catalog number 626631US, is being recalled by Integra LifeSciences Corp. The record states the kit is indicated when direct intracranial pressure monitoring is required, for both subdural and intraparenchymal pressure monitoring applications.
The reason given in the enforcement record is potential corrosion stains on the surface of the 14-gauge Tuohy needle that is included in the Microsensor and Cerelink ICP kits.
The record lists 1,301 units carrying UDI-DI 10381780514473, across lots including 7288007, 7288040, 7294017, 7305988 and 7305989. Distribution was worldwide, including nationwide across the United States. The FDA has classified the action as Class II.
The record describes surface staining on a kit component and states no consequence or reported injuries. Facilities should quarantine affected lots and follow Integra's instructions.
The recalled product
- Product
- Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- corrosion
- needle
- component-defect
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 (20)
- Catalog Number: 626631US. UDI-DI: 10381780514473. Lot Numbers: 7288007
- 7288040
- 7294017
- 7305988
- 7305989
- 7305990
- 7305991
- 7307683
- 7325489
- 7336088
- 7336089
- 7336090
- 7305992
- 7346223
- 7391752
- 7391751
- 7406650
- 7406651
- 7406652
- 7408825
Distribution
Distributed nationwide across the United States.
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