Z-0042-2023Class II

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028

Name: Z-0042-2023 Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
Creator: Hobbs Medical, Inc.
Published: 2022-07-29
License: https://open.fda.gov/license/

Hobbs Medical, Inc. / initiated 2022-07-29 / Open, Classified / root cause: manufacturing process

FDA source

Hobbs Medical, Inc. began a recall of Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 on 2022-07-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0042-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-29
Posted: 2022-10-07
Recalling firm: Hobbs Medical, Inc.
Product: Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
Product code: FAD Stent, Ureteral
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.)
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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 [email protected] Return instructions are provided on the Acknowledgement Form
Quantity in commerce: 3 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Product codes and lots: UDI-DI: M84960280 Lot Numbers: H02-19-021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0042-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0010-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0011-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0012-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0013-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0014-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0015-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0016-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0017-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0018-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0019-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0020-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0021-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0022-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0023-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0024-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0025-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0026-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0027-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0028-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0029-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0030-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0031-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0032-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0033-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0034-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0035-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0036-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0037-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0038-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0039-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0040-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0041-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0042-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0043-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0044-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0045-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0046-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0047-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0048-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0049-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0050-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0051-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0052-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0053-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0054-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0055-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0056-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0057-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0058-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0059-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0060-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0061-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0062-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0063-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0064-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0065-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0066-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0067-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0068-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0069-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07
Z-0070-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-07

Product code FAD

K834401Class IIUreteral Double Pigtail StentHobbs Medical, Inc. / cleared 1984-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)