[Recalled] Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108 — Device label display an incorrect expiration date, extends the shelf life of th… | FDA 2022-07-29
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108 |
|---|---|
| Brand / manufacturer | Hobbs Medical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0045-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 29 July 2022 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
This Class II 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
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Hobbs Medical, Inc.
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.