Medical Device Recall: Z-0028-2023

FDA Recalls dataset · Firm: Hobbs Medical, Inc. · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2022-07-29 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-2023.

Recall Res Number
Z-0028-2023
Recalling Firm / Manufacturer
Hobbs Medical, Inc.
FEI Number
1220592
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2022-07-29
Date Posted
2022-10-07
Date Terminated
N/A
Product Code
OCZ
Event Number
90769
Product Quantity
3 units
Product Description Hobbs Helical Retrieval Basket Catalog Number: 4814
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.)
Action Details 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
Distribution Pattern Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Code Information / Serial Numbers UDI-DI: M84948140 Lot Numbers: H10-17-098R

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.