FDA Medical Device Recalls (openFDA)
Infusion Pump Repair: Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
- Recall number
- Z-1544-2021
- Recalling firm
- Infusion Pump Repair
- Product
- Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
- Status
- Open, Classified
- Initiated
- 2021-03-26
- Posted
- not on file
- Terminated
- not on file
- 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 03/26/2021, Voluntary Field Safety Corrective Action notices started being mailed to customers. The firm conducted further communications via email and phone. The firm asked customers with pumps serviced with the affected bezels to return the pump module units to the recalling firm so they could swap out the affected bezels or provide a refund. The firm asked customers to immediately share this field safety corrective action notification with all necessary parties within your organization to ensure that they are also aware of this action. Also, please complete and return the Customer Response Form. Customers can contact the recalling firm at: 855-477-8866 or info@infusionpumprepair.com
- Quantity
- 15
- Distribution
- California
- Lot, serial or model codes
- Devices distributed between 01/15/2021 and 03/14/2021. Sale Order #/Serial #: 1599930872/ 12335834, 13617863, 13447266, 13089105, 12333728, 13616451, 13618575, 12729374; 82943/ 4122252, 4122320; 01112101A/ 12638236, 13813590, 12639090, 13744738, 9951014
- 510(k) numbers
- K133532
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3011655432
- Firm city
- Irvine
- 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