Abbott Vascular Plus 30 Priority Pack Recalled for Connection Leaks
Abbott Vascular is recalling seven lots of the Plus 30 Priority Pack due to increased reports of leaks and intermittent loose connections in the vascular devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a quality issue without reported illnesses or injuries. The hazard involves device leaks and loose connections, making it a risk-of-harm product, but no adverse outcomes have been documented in the source material.
Plain-English summary
Abbott Vascular is recalling seven lots of its Plus 30 Priority Pack vascular devices. The recall involves two product variants: the Plus 30 Priority Pack w/.096 RHV (Reference 1000183) and the Plus 30 Priority Pack w/.115 RHV (Reference 1000185-115).
The recall is due to an increase in complaint trends regarding leaks and intermittent or loose connections in the devices.
The affected lots have been distributed nationwide across the United States as well as internationally to numerous countries including the United Arab Emirates, France, Pakistan, Canada, Mexico, United Kingdom, Australia, and others.
The recalled product
- Product
- Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Vascular Device
- Hazard
- leak
- loose-connection
Distribution
Distributed nationwide across the United States.
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