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Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

FDA Recall #Z-0048-2023 — Class II — July 29, 2022

Recall #Z-0048-2023 Date: July 29, 2022 Classification: Class II Status: Ongoing

Product Description

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

Reason for Recall

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.)

Recalling Firm

Hobbs Medical, Inc. — Stafford Springs, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

14 units

Distribution

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

Code Information

UDI-DI: M84963520 Lot Numbers: H04-18-014R

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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