Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Reported: May 19, 2021 Initiated: March 26, 2021 #Z-1544-2021
Product Description
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Reason for Recall
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Details
- Recalling Firm
- Infusion Pump Repair
- Units Affected
- 15
- Distribution
- California
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part. Recalled by Infusion Pump Repair. Units affected: 15.
Why was this product recalled? ▼
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Critical. Recall number: Z-1544-2021.
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