The Recall Desk
HighFDA (Devices)·Z-0922-2022·Announced 2022-04-20

FDA Recalls Abbott Vascular Priority Pack Accessory Kits for Leak and Connection Issues

Abbott Vascular is recalling 23 lots of Priority Pack accessory kits and packs due to reports of leaks and loose connections in the 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: FDA Class II recall for a medical device with potential device malfunction risk from leaks and loose connections. No illnesses or injuries reported, but the potential for patient harm from connection failure warrants a High classification.

Plain-English summary

Abbott Vascular is recalling 23 lots of its 20/30 Priority Pack Accessory Kit and 20/30 Priority Pack products due to an increasing trend of complaints involving leaks and loose connections. The affected product lots include Part Number 1000186 (Device Identifier 08717648013614) and Part Number 1000186-115 (Device Identifier 08717648015274).

These devices were distributed nationwide across all U.S. states and territories, as well as internationally to countries including Canada, Mexico, the United Kingdom, France, Australia, Germany, Japan, and others.

The recall was initiated in response to reports of leaks and intermittent or loose connections affecting the devices. No specific information about reported illnesses or injuries has been made available in this recall notice.

Healthcare providers and patients who have received these devices should contact Abbott Vascular or their healthcare provider for guidance on replacement or alternative options.

The recalled product

Product
20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
Manufacturer
Abbott Vascular
Category
Medical Device — Vascular access device
Hazard
Affected units
23

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Abbott Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

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Same hazard · device leak

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