FDA Medical Device Recalls (openFDA)
STEP-HAR MEDICAL LLC: Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
- Recall number
- Z-1543-2021
- Recalling firm
- STEP-HAR MEDICAL LLC
- Product
- Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
- Status
- Terminated
- Initiated
- 2021-02-26
- Posted
- 2021-05-10
- Terminated
- 2024-08-15
- 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.
- Root cause
- Component design/selection
- 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 stdoan@stepharmedical.com
- Quantity
- 2
- Distribution
- IA
- Lot, serial or model codes
- Serial Numbers: 12747983 and 9919591
- 510(k) numbers
- ["K133532"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3017540525
- Firm city
- Fountain Valley
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28