[Recalled] Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 — Bezel repair parts used, not by the original manufacturer, to service and repai… | FDA 2021-02-25
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 |
|---|---|
| Brand / manufacturer | Tenacore LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1332-2021 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 25 February 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.