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Recall Observatory FDA recall evidence

Device product

Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507

Z-0051-2023

July 29, 2022

Class II

Product summary

Firm
Hobbs Medical, Inc.
Event
Event 90769
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0051-2023

Official wording

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.)

Code information: UDI-DI: M84965070 Lot Numbers: H08-18-075

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label display an incorrect