Health product recall

Indeflator Device

Brand(s)
Last updated

Summary

Product
Indeflator Device
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Indeflator Plus 30 Inflation Device More than 10 numbers, contact manufacturer. 1000183, 1000185
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

Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated rate of occurrence of air ingress associated with the device is 0.4%. While no long-term adverse patient effects have been associated with this issue, potential risks include air embolism, thrombosis and foreign body in patient.

Recall start date: Mar 11, 2022

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
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64029

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