Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error
Arrow International Inc. is recalling 165 units of FiberOptix Intra-Aortic Balloon Catheter Kits because the outer package label incorrectly identifies the product size.
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 involves a minor labeling error regarding product identification, which fits the rubric criteria for moderate severity.
Plain-English summary
Arrow International Inc. is recalling 165 units of the ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr (Product Code: IAB-05840-LWS). The recall is due to a labeling error on the outer package, which incorrectly identifies the product as "FiberOptix Flex IAB 7.5Fr" rather than the correct "FiberOptix IAB 8Fr".
The affected units were distributed nationwide in the United States and internationally to Belgium. The specific lot number for the recalled product is 18F14M0001.
Healthcare providers and consumers should stop using the affected product and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 165
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: 18F14M0001
Distribution
Distributed nationwide across the United States.
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Similar recalls
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