FDA Device Recall Z-0010-2023: Hobbs Medical, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-2023.

Recall Res Number

Z-0010-2023

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

OCX

Event Number

90769

Product Quantity

275 units

Product Description Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190

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 UD-DI: M84921900 Lot Numbers: H02-18-166R H02-18-167R H02-18-168R H02-18-169R H04-18-214R H11-17-182R

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Medical Device Recall: Z-0010-2023

Recall Parameters & Description

Related Establishments / Registrations

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