FDA Recall
Terminated
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Recall: Z-1543-2021
·
Initiated February 26, 2021
Recall
- Recall Number
- Z-1543-2021
- Event Number
- 87773
- Firm
- STEP-HAR MEDICAL LLC
- FEI Number
- 3017540525
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- February 26, 2021
- Posted
- May 10, 2021
- Terminated
- August 15, 2024
- Address
- 11237 Slater Ave, Fountain Valley, CA, 92708-5417
Description
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
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.
Action
On 02/26/2021, the one customer was notified of the recall via phone call and email. On 04/15/21, a Voluntary Field Safety Corrective Action notice were mailed. The firm asked their customer to respond so the bezel repair part could be replaced. Customers can contact the recalling firm at: 657-267-0054 or [email protected]
Distribution
IA
Quantity
2