STEP-HAR MEDICAL LLC Recall 87773
Description: Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
STEP-HAR MEDICAL LLC Recall 87773 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1543-2021 |
| Event ID | 87773 |
| Event Description | Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part |
| Product Type | Devices |
| Distribution | IA |
| Quantity | 2 |
| Recall Reason | 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. |
| Device Classification | 20210519 |
| Device Code Info | Serial Numbers: 12747983 and 9919591 |
| Center Classification Date | 20210510 |
| Recall Initiation Date | 20210226 |
| Recalling Firm | STEP-HAR MEDICAL LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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