20/30 Priority Pack Accessory Kit With Copilot and 20/30 Indeflator Inflation Device
Brand(s)
Last updated
Summary
Product
20/30 Priority Pack Accessory Kit With Copilot and 20/30 Indeflator Inflation Device
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| 20/30 Priority Pack Accessory Kit With Copilot | More than 10 numbers, contact manufacturer. | 1003327 |
| 20/30 Indeflator Inflation Device | More than 10 numbers, contact manufacturer. | 1000184 1000186 1000186-115 |
Issue
This action is being taken due to an increased potential for a leak in the indeflator at the hose rotating luer or at the guage. Analysis indicates an estimated rate of occurrence of leaks ranging from 0.3% to 2.3% across the impacted lots. While no adverse patient effects have been reported with this issue, potential risks include air embolism.
Recall Start Date: November 6, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Abbott Vascular
3200 Lakeside Drive, Santa Clara, California, United States, 95054-2807
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-76554
Get notified
Receive notifications for new and updated recalls and alerts by category.