Ivenix Infusion System (IIS)
Reported: July 20, 2022 Initiated: April 22, 2022 #Z-1381-2022
Product Description
Ivenix Infusion System (IIS)
Reason for Recall
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
Details
- Recalling Firm
- Ivenix, Inc.
- Units Affected
- 1335 devices
- Distribution
- US Nationwide distribution in the states of NJ and WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS). Recalled by Ivenix, Inc.. Units affected: 1335 devices.
Why was this product recalled? ▼
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1381-2022.
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