Hobbs Medical recalls Freeman Pancreatic Flexi-Stent (Catalog 6534) with incorrect expiration dates extending shelf life. Affected units sold in the US from March 2018 to September 2020 with specific lot numbers ending in R.
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-Stents with catalog number 6534 due to incorrect expiration dates that extend the product's shelf life. This could lead to using devices past their intended safe period, potentially causing issues with the medical device's performance.
The device label shows an incorrect expiration date, which extends the product's shelf life beyond what is safe. This means the device might be used past its intended safe period, potentially affecting its performance in medical procedures.
Patients who received this medical device for pancreatic treatment are likely affected. Those with devices having lot numbers ending in 'R' are most at risk.
Check for the catalog number 6534 on the device. Look for lot numbers ending in 'R' or kits containing at least one device with a lot number ending in 'R'.
Look for lot numbers ending in 'R' on the device or kit.
The recall record does not specify the correct expiration date.
Check for lot numbers ending in 'R' on the device or kit.
The recall does not require stopping use; it only identifies devices with incorrect expiration dates.
We’ve drafted a message you can send Hobbs Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0056-2023 — Hobbs Medical Hobbs Medical Hello, I own a Hobbs Medical that is covered by recall Z-0056-2023 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.
