Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits (Catalog 6501) with incorrect expiration dates extending shelf life. Affected units sold 3/25/2018 to 9/28/2020 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-Stent Kits (Catalog 6501) because they have incorrect expiration dates that extend the product's shelf life. This could lead to using expired medical devices that may not function properly.
The stent kits have expiration dates that are incorrect, meaning they may be used beyond their actual shelf life. This could result in medical devices not functioning properly during procedures, potentially affecting patient safety.
Healthcare professionals who use these stent kits for pancreatic procedures are most at risk. Patients receiving these treatments may also be affected if the kits are used improperly.
Check for the catalog number 6501 on the product. Look for lot numbers ending in 'R' or kits containing at least one device with a lot number ending in 'R'. These were distributed in the US from March 25, 2018, to September 28, 2020.
Look for lot numbers ending in 'R' on the product or kit.
The recall record does not specify the correct expiration date.
Check for catalog number 6501 and lot numbers ending in 'R' on the product or kit.
The recall does not specify a stop-use action; the hazard is low risk.
We’ve drafted a message you can send Hobbs Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0049-2023 — Hobbs Medical Hobbs Medical Hello, I own a Hobbs Medical that is covered by recall Z-0049-2023 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.
