Indeflator Device
Brand(s)
Summary
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
Abbott Vascular
3200 Lakeside Drive, Santa Clara, California
United States, 95054-2807