The Recall Desk
HighFDA (Devices)·Z-0066-2023·Announced 2022-10-19

Freeman Pancreatic Stent Recall: Incorrect Expiration Date on Device Labels

Freeman Pancreatic Flexi-Stents with incorrect expiration dates on labels may be used beyond their validated shelf life. The recall affects devices distributed in the US and five other countries from March 2018 through September 2020.

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 an FDA Class II recall involving mislabeled expiration dates on medical devices. The hazard is material: use of expired pancreatic stents beyond their validated shelf life could compromise device sterility and functionality. No illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported per FDA severity criteria.

Plain-English summary

Freeman Pancreatic Flexi-Stents (kit 6501, catalog number 6541) manufactured by Hobbs Medical, Inc. have been recalled due to incorrect expiration dates displayed on device labels. The mislabeled expiration dates extend the shelf life of the devices beyond their actual validated period, creating a potential safety risk if devices are used when expired.

The affected devices were distributed in the United States, Canada, Austria, Belgium, Finland, and Norway. Distribution occurred between March 25, 2018, and September 28, 2020. Affected devices can be identified by lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R." The incorrect labels show expiration dates between November 1, 2022, and September 1, 2025.

Healthcare providers and patients should verify their device lot numbers against the recall. Do not use affected devices beyond the correct expiration date established by the manufacturer. Contact your physician or Hobbs Medical, Inc. for verification of the proper expiration date for your device and for further information.

The recalled product

Product
Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Pancreatic Stents
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 Kit Lot Number: H09-18-008

Distribution

Distributed nationwide across the United States.

Related recalls

Same category