Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
Summary
The FDA issued a Class II for Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 by Hobbs Medical, Inc.. 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.
Details
Source
Device Recall
External ID
Z-0049-2023
Action Date
2022-10-19
Status
Ongoing
Category
device
Product Description
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
Lot/Code Info: UDI-DI: M84965010 Lot Numbers: H09-18-008
Quantity Affected: 10 units
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.)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-29
Company
Stafford Springs, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hobbs Medical, Inc. has 73 FDA actions in our database, including 72 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hobbs Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hobbs Medical, Inc. have FDA actions?
Hobbs Medical, Inc. has 73 FDA actions in our database, including 72 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0049-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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