The Biomed Guys Recall 87768
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.
The Biomed Guys Recall 87768 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1651-2021 |
| Event ID | 87768 |
| Event 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. |
| Product Type | Devices |
| Distribution | Us distribution to the states of IN and TX. |
| Quantity | 22 units |
| Recall 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. |
| Device Classification | 20210609 |
| Device 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, |
| Center Classification Date | 20210601 |
| Recall Initiation Date | 20210325 |
| Recalling Firm | The Biomed Guys |
| Initial Notification | |
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