Alaris Pump Module, Model 8100, serviced/repaired by… recallZ-1543-2021 · Step-Har Medical LLC · initiated Feb 26, 2021
Class I Terminated All recalls posted in May 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Step-Har Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component design/selection
What the company is doing
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]
Recall details
- Recall number
- Z-1543-2021
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Feb 26, 2021
- Posted by the FDA
- May 10, 2021
- Recalling firm
- Step-Har Medical LLC
- Quantity
- 2
- Product code
- FRN
- FDA submissions
- K133532
- Distribution
- IA
Product description
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Code information (models, lots, serial numbers)
Serial Numbers: 12747983 and 9919591
Other devices under the same FDA submission
4 devices cleared under K133532 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion1 recall2 deaths5,636 reports
- Alaris 8975Carefusion 303, Inc. · Infusion safety management software169 reports
- Alaris 9601Carefusion 303, Inc. · Pump, infusion1 recall0 reports
- Alaris™ Syringe Module, Model 8110 8100Carefusion 303, Inc. · Pump, infusion14 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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