Hobbs Medical recalls Freeman Pancreatic Flexi-Stent (Catalog 6535) with incorrect expiration dates extending shelf life. Devices distributed in the US from March 2018 to September 2020 with lot numbers ending in R are affected.
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 devices with incorrect expiration dates that extend their shelf life. This means the products may remain usable longer than intended, potentially leading to safety issues if used beyond their actual expiration.
The device label shows an incorrect expiration date, which extends the shelf life beyond what is safe. This could lead to the device being used after its actual expiration date, potentially causing safety issues if the device degrades over time.
Patients who received Freeman Pancreatic Flexi-Stent devices with lot numbers ending in R, distributed in the US between March 2018 and September 2020. Medical professionals using these devices for pancreatic procedures are most at risk.
Check for lot numbers ending in 'R' on the device packaging. Devices distributed in the United States from March 25, 2018, to September 28, 2020, with expiration dates between November 1, 2022, and September 1, 2025, are affected.
Look for lot numbers ending in 'R' on the device packaging or documentation.
The recall record does not specify the correct expiration date.
Devices with lot numbers ending in 'R' distributed in the US from March 25, 2018, to September 28, 2020, are affected.
The recall record does not mention a return or remedy action.
We’ve drafted a message you can send Hobbs Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0057-2023 — Hobbs Medical Hobbs Medical Hello, I own a Hobbs Medical that is covered by recall Z-0057-2023 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.