Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kit (Catalog 6352) with incorrect expiration dates extending shelf life. Affected units distributed in the US from March 2018 to September 2020.
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.)
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent Kit Catalog Number 6352 due to incorrect expiration dates that extend the product's shelf life. This could lead to using devices beyond their intended safe period.
The device label shows an incorrect expiration date, which extends the product's shelf life beyond what is safe. This could mean the device is used after its intended expiration date, potentially causing issues with effectiveness or safety.
Healthcare professionals who use this medical device kit are most at risk. Patients receiving the device may also be affected if the incorrect expiration date leads to improper use.
Check for the catalog number 6352 on the device. Lot numbers ending in 'R' (e.g., H04-18-014R) or kits containing at least one device with such a lot number are affected. Products were distributed in the US from March 25, 2018, to September 28, 2020.
Look for the catalog number 6352 and lot numbers ending in 'R' on the device.
The device label shows an incorrect expiration date that extends the shelf life of the product beyond its intended safe period.
The official recall notice does not specify a remedy or action steps for affected products.
Products were distributed in the United States from March 25, 2018, to September 28, 2020.
We’ve drafted a message you can send Hobbs Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0048-2023 — Hobbs Medical Hobbs Medical Hello, I own a Hobbs Medical that is covered by recall Z-0048-2023 from Hobbs Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.