| Class 2 Device Recall Hobbs | |
Date Initiated by Firm | July 29, 2022 |
Date Posted | October 07, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0012-2023 |
Recall Event ID |
90769 |
510(K)Number | K914358 |
Product Classification |
Catheter, ureteral, gastro-urology - Product Code EYB
|
Product | Hobbs Medical Flex-Ez Guide Wire
Disposable For endoscopy procedures
Ref: 3412 |
Code Information |
UD-DI: M84934120
Lot Numbers:
H05-18-091R |
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 | 32 units |
Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = EYB
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