Galt Medical Recalls Centeze Centesis Catheters Due to Tip Geometry Defect
Galt Medical Corporation is recalling 9,920 Centeze Centesis Catheters because a manufacturing issue resulted in incorrect tip geometry, specifically a thicker wall and more obtuse tip angle.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Galt Medical Corporation is recalling 9,920 units of Centeze Centesis Catheters, 6F, 10cm, 18Ga, 12cm. The recall involves two catalog numbers: DRC-002-06 and DRC-006-16. The affected units were distributed in the United States (Florida, Georgia, Massachusetts, North Carolina, New Jersey, Ohio, Pennsylvania, Puerto Rico, and Utah) and internationally in Canada, the Netherlands, Turkey, the United Kingdom, and the UAE.
The recall was initiated due to a manufacturing issue where the catheter tip geometry is incorrect. Specifically, the catheter tip has a thicker wall, resulting in a more obtuse tip angle. This defect is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and distributors should stop using the affected catheters and contact Galt Medical Corporation for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Catheters
- Hazard
Distribution
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