The Recall Desk
HighFDA (Devices)·Z-0061-2023·Announced 2022-10-19

Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Dates

Hobbs Medical recalled Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on labels that extend the shelf life, potentially allowing use beyond 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: FDA Class II medical device recall where incorrect expiration dating extends shelf life, creating a risk-of-harm situation if devices are used beyond their true expiration date.

Plain-English summary

Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent devices (Catalog Number 6566) due to incorrect expiration dates on device labels. The labeling error extends the shelf life, potentially allowing use of devices beyond their intended expiration period.

Affected devices were distributed in the United States from March 25, 2018, through September 28, 2020. Specifically, devices with lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R" are affected. The incorrect expiration dates on affected labels range from November 1, 2022, to September 1, 2025. The product was also distributed internationally to Canada, Austria, Belgium, Finland, and Norway.

The recalled product

Product
Freeman Pancreatic Flexi-Stent Catalog Number: 6566
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Pancreatic Stent
Hazard
  • mis-labeling
  • expiration-error

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: M84965660 Lot Numbers: H01-18-204R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category