Health product recall

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

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