Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
- Company
- The Biomed Guys
- Recall Initiated
- March 25, 2021
- Recall Number
- Z-1651-2021
- Quantity
- 22 units
- Firm Location
- Clarksville, TN
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.
Distribution
Us distribution to the states of IN and TX.
Lot / Code Info
Serial numbers of serviced devices, serviced 09/2020-02-2021: 12833065, 13187021, 13187811, 12838069, 12982509, 12837231, 12835186, 12837972, 12710593, 12776790, 13753893, 13605919, 12832544, 15763526, 14806203, 14806612, 14807070, 13738432, 15763547, 15865626, 14806472, 12796415,
Root Cause
Under Investigation by firm
Action Taken
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.