The Recall Desk
HighFDA (Devices)·Z-0065-2023·Announced 2022-10-19

Freeman Pancreatic Flexi-Stent label displays incorrect expiration date

Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on their labels. The labeling error extends the shelf life beyond the intended timeframe.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for an incorrect expiration date label. The error extends the shelf life beyond the intended date, creating a risk that expired devices could be used in clinical procedures. No injuries or illnesses have been reported. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent devices (Catalog Number 6584) because the product label displays an incorrect expiration date. This labeling error extends the shelf life of affected devices beyond the intended timeframe.

Devices with an extended shelf life could be used after their actual expiration date. The recall covers devices distributed between March 25, 2018, and September 28, 2020, with expiration dates between November 1, 2022, and September 1, 2025.

Affected devices were distributed worldwide in the United States, Canada, Austria, Belgium, Finland, and Norway. Specifically, devices with lot numbers ending in R, or kits containing at least one device with a lot number ending in R, are affected by this recall.

Healthcare facilities and practitioners should verify the expiration date of their Freeman Pancreatic Flexi-Stent devices and discontinue use if the device may exceed its actual shelf life.

The recalled product

Product
Freeman Pancreatic Flexi-Stent Catalog Number: 6584
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Pancreatic Stent
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: M84965840 Lot Numbers: H07-16-033R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category