Abbott Fast-Cath Trio Hemostasis Introducer Recalled for Incorrect Size
Abbott Medical is recalling 814 Fast-Cath Trio Hemostasis Introducer devices because they contain 12F components instead of the expected 14F size.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a manufacturing error (incorrect size) without reported adverse health consequences, fitting the Moderate criteria for low-risk issues or voluntary precautionary recalls.
Plain-English summary
Abbott Medical is recalling 814 units of the Fast-Cath Trio Hemostasis Introducer, 14F, 4.6 mm, REF 406303. The recall was initiated because the devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
The affected devices were distributed worldwide, including nationwide in the United States in the states of Florida, Pennsylvania, New York, Texas, Michigan, California, Illinois, Nebraska, Alabama, and Nevada, as well as Puerto Rico. International distribution included Malaysia, Korea, and Paraguay. The specific batch number is 7133555.
Healthcare providers and facilities should stop using the affected devices and contact Abbott Medical for further instructions. Consumers are not expected to use these devices directly, as they are medical devices intended for professional use.
The recalled product
- Product
- Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
- Manufacturer
- Abbott Medical
- Hazard
- Affected units
- 814
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 (2)
- UDI: (01)15414734203903(17)220731(10)7133555
- Batch: 7133555
Distribution
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