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U.S. Department of Health and Human Services

Class 2 Device Recall Hobbs

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  Class 2 Device Recall Hobbs see related information
Date Initiated by Firm July 29, 2022
Date Posted October 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0052-2023
Recall Event ID 90769
510(K)Number K834351  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product Freeman Pancreatic Flexi-Stent Kit (containing 6566)

Catalog Number: 6518
Code Information UDI-DI: M84965180 Lot Numbers: H08-18-118 H08-18-212
Recalling Firm/
Manufacturer		 Hobbs Medical, Inc.
8 Spring St
Stafford Springs CT 06076-1505
For Additional Information Contact Hobbs Medical Customer Service
800-344-6227
Manufacturer 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.)
FDA Determined
Cause 2		 Process control
Action Hobbs Medical issued URGENT RECALL letter via Certified Mail with return receipt requested on 7/29/22. Letter states reason for recall, health risk and action to take: 1. Read the Description of the problem section. 2. Immediately identify and set aside all product listed herein in a manner that ensures the affected product will not be used and will be returned to Hobbs Medical. 3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs Medical Customer Service, return via Fax at 860-684-7574, or email to CustomerService@HobbsMedical.com. 4. Pass on this notice to anyone in your facility that needs to be informed according to your internal notification procedures. 5. If any product listed below has been forwarded to another facility, contact that facility to arrange return. 6. Maintain awareness of this notice until all product listed above has been returned to Hobbs Medical. For questions related to the issue, the Acknowledgement form, and product replacement, please contact Hobbs Medical Customer Service at: 1-800-344-6227 CustomerService@hobbsmedical.com Return instructions are provided on the Acknowledgement Form
Quantity in Commerce 2 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = HOBBS MEDICAL, INC.
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