The Recall Desk
HighFDA (Devices)·Z-0062-2023·Announced 2022-10-19

Freeman Pancreatic Flexi-Stent recalled for incorrect expiration date labeling

Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The labeling error extends the stated shelf life, potentially allowing use of degraded devices.

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 labeling error on a high-risk medical device where the incorrect expiration date extends the stated shelf life, creating a risk of device degradation and failure. No illnesses or injuries have been reported, making this a risk-of-harm scenario without reported harm, which per the rubric warrants a score of 3 (High).

Plain-English summary

Hobbs Medical, Inc. is recalling the Freeman Pancreatic Flexi-Stent (Catalog Number 6567) due to incorrect expiration date labeling. The device labels display expiration dates that do not accurately reflect the actual shelf life of the product.

The affected devices have lot numbers ending in 'R' and were distributed between March 25, 2018 and September 28, 2020. The incorrect labels show expiration dates between November 1, 2022 and September 1, 2025. When devices are used beyond their actual intended shelf life, they may degrade and fail to function as designed, potentially compromising patient safety during medical procedures.

The affected devices were distributed worldwide, including throughout the United States and in Canada, Austria, Belgium, Finland, and Norway. Healthcare providers and patients who have these devices should verify the actual lot number and expiration date against the manufacturer's records.

Patients and healthcare providers who have affected devices should contact Hobbs Medical, Inc. for guidance on verification, replacement, or proper handling of the recalled product.

The recalled product

Product
Freeman Pancreatic Flexi-Stent Catalog Number: 6567
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Surgical / Interventional
Hazard
  • expiration-date-mislabeling
  • device-degradation-risk

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: M84965670 Lot Numbers: H02-18-262R

Distribution

Distributed nationwide across the United States.

Related recalls

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