FDA Medical Device Recalls (openFDA)
Tenacore LLC: Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
- Recall number
- Z-1332-2021
- Recalling firm
- Tenacore LLC
- Product
- Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
- Status
- Terminated
- Initiated
- 2021-02-25
- Posted
- 2021-04-02
- Terminated
- 2024-08-05
- 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 02/25/2021, Field Safety Corrective Action notifications were mailed to customers; customers were also notified via phone. The recalling firm provided the following services to customers: serviced infusion pumps, sold infusion pumps, and sold bezel repair parts. Customers were asked to do the following: 1. Review the serialized list of potentially impacted pumps and remove these devices from clinical use and immediately quarantine them until they can be inspected, and impacted parts are replaced, if necessary. Part customers were told to quarantine affected parts. 2. Inspect the potentially affected devices to determine if the impacted bezel repair part is installed. Refer to inspection instructions and a) identify the impacted Alaris 8100 Infusion Pump Module by serial number; b) Look from the top down for the ejector pin marks, c) If NO ejector pin marks are identified, this module requires bezel. Customers who were sold pumps can identify affected pumps through serial number alone. 3. Dealers and Distributors only: If potentially impacted pumps were sold, immediately identify, inspect and recall, if necessary, the potentially affected pumps. An electronic copy of a proposed field safety corrective action notice will be provided that can to be used for the facilities that may be using the potentially affected pumps. 4. Contact the recalling firm to schedule bezel repair part replacement. The impacted bezel repair part must be replaced before the pump can be returned to service. 5. Please 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. Notify end user customers. 6. Complete and return the customer response form. Contact Quality Assurance at 714-371-9919 or Quality@Tenacore.com to schedule replacement of the impacted part.
- Quantity
- 1494
- Distribution
- US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
- Lot, serial or model codes
- Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392
- 510(k) numbers
- ["K133532"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3008403701
- Firm city
- Santa Ana
- 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