FDA Recall
Open, Classified
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Recall: Z-1651-2021
·
Initiated March 25, 2021
Recall
- Recall Number
- Z-1651-2021
- Event Number
- 87768
- Firm
- The Biomed Guys
- FEI Number
- 3018685909
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 25, 2021
- Address
- 1865 Ashland City Rd, Ste H, Clarksville, TN, 37043-6455
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
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.
Action
The firm notified their consignees via email 3/25/2021 and multiple phone calls 3/25/2021, 3/26/2021 & 3/30/2021. Customers where also sent empty boxes with packing material to return their affected devices for inspection and remediation.
Distribution
Us distribution to the states of IN and TX.
Quantity
22 units