Hobbs Helical Retrieval Basket Catalog Number: 4824
- Company
- Hobbs Medical, Inc.
- Recall Initiated
- July 29, 2022
- Posted
- October 7, 2022
- Recall Number
- Z-0031-2023
- Quantity
- 10 units
- Firm Location
- Stafford Springs, CT
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.
Lot / Code Info
UDI-DI: M84948240 Lot Numbers: H02-17-159R
Root Cause
Process control
Action Taken
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