FDA Device recall Z-1332-2021
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
- FDA Device
- Class I
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class I recall of Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 by Tenacore, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1332-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-02-25 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tenacore |
| Distribution | AZ, CA, DE, FL, KY, LA, ME, MN, MO, NC, NV, NY, PA, TN, TX, WA |
Product
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
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.
Identifiers
| code_info | Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers:…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1332-2021%22
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