Product Wiki · Recalls · U.S. FDA — Device Enforcement

Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027 — recall Z-0041-2023

U.S. FDA — Device Enforcement · United States · 2022-07-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0041-2023
Date of alert
2022-07-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hobbs Medical, Inc.
Product category
device
Product type
Devices
Reported risk: 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.)
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.