Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Reported: June 9, 2021 Initiated: March 25, 2021 #Z-1651-2021
Product Description
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Reason for Recall
Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
Details
- Recalling Firm
- The Biomed Guys
- Units Affected
- 22 units
- Distribution
- Us distribution to the states of IN and TX.
- Location
- Clarksville, TN
Frequently Asked Questions
What product was recalled? ▼
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.. Recalled by The Biomed Guys. Units affected: 22 units.
Why was this product recalled? ▼
Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 9, 2021. Severity: Critical. Recall number: Z-1651-2021.
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