Concentric Medical Recalls Distal Access Catheters Due to Incorrect Labeling
Concentric Medical is recalling 87 Distal Access Catheters because they were shipped with Directions for Use containing instructions for aspiration, which are only approved outside the US.
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: This is a Class II recall involving a labeling error (incorrect Directions for Use) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Concentric Medical Inc is recalling 87 units of Distal Access Catheters (Model Numbers 90121, 90130, 90131, and 90160). The devices were shipped to US customers with a version of the Directions for Use (DFU) that included instructions for aspiration. This specific version of the DFU is only approved for use outside of the United States.
The recall involves eight specific lot numbers: 36007, 35767, 35980, 35951, 36050, 36017, 36029, and 35583, with manufacturing dates ranging from February 2014 to September 2014. The affected units were distributed to customers in the following US states: Texas, Tennessee, Pennsylvania, Michigan, Virginia, California, North Carolina, Mississippi, Florida, Illinois, Massachusetts, Arizona, Oklahoma, New York, Kentucky, Washington, and Alabama.
The FDA has classified this as a Class II recall. The hazard is related to the use of an unapproved version of the instructions for use in the US market. Users should verify the lot numbers of their devices against the list provided and contact the manufacturer for further instructions.
The recalled product
- Product
- Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the…
- Manufacturer
- Concentric Medical Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 87
Distribution
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