Recall Z-0064-2023— Hobbs Medical, Inc.

Name: FDA recall Z-0064-2023
Creator: U.S. Food and Drug Administration
Published: 2022-07-29

Class II · Ongoing

Class II FDA medical device recall by Hobbs Medical, Inc., initiated 2022-07-29. It names one FDA 510(k) clearance: K834351. Product: Freeman Pancreatic Flexi-Stent Catalog Number: 6582. Reason: 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.).

Recalling firm: Hobbs Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-07-29
Firm location: Stafford Springs, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K834351 — BILIARY INDWELLING STENTHobbs Medical, Inc.·cleared 1984-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Freeman Pancreatic Flexi-Stent Catalog Number: 6582

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.)

Data sourced from openFDA. This site is unofficial and independent of the FDA.