FDA Device recall Z-0041-2023
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
- FDA Device
- Class II
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027 by Hobbs Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0041-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-29 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hobbs Medical |
| Distribution | US |
Product
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
Reason
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.)
Identifiers
| code_info | UDI-DI: M84960270 Lot Numbers: H01-19-241 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0041-2023%22
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