Alaris Pump Module recall
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Why was Alaris Pump Module recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 12747983 and 9919591
- Product
- Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
- Recalling firm
- STEP-HAR MEDICAL LLC
- Quantity
- 2
- Distribution
- IA
- Recall date
- May 19, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)