The Recall Desk
ModerateFDA (Devices)·Z-0048-2023·Announced 2022-10-19

Freeman Pancreatic Flexi-Stent Kit recalled for mislabeled expiration dates

Hobbs Medical is recalling the Freeman Pancreatic Flexi-Stent Kit because the device label displays an incorrect expiration date that extends the shelf life. U.S. distribution of affected devices occurred between March 25, 2018 and September 28, 2020.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for a labeling error regarding expiration dates. No reported illnesses or injuries. The hazard is theoretical—potential use of expired devices—but harm has not been reported.

Plain-English summary

The Freeman Pancreatic Flexi-Stent Kit (Catalog Number: 6352) manufactured by Hobbs Medical, Inc. is being recalled. The device label displays an incorrect expiration date, which extends the shelf life of the product beyond the actual expiration date.

The recall affects 14 units with lot numbers ending in 'R' or kits containing at least one device with a lot number ending in 'R'. The affected devices were distributed in the United States from March 25, 2018 to September 28, 2020, and also to Canada, Austria, Belgium, Finland, and Norway. The UDI-DI for affected devices is M84963520 and the lot number is H04-18-014R.

Using a medical device with an incorrect expiration date on the label could result in the use of an expired device, which may have compromised safety or effectiveness. Consumers and healthcare providers should verify the actual expiration date of affected devices and discontinue use of any devices that have exceeded their true expiration. Contact Hobbs Medical, Inc. for instructions on replacement or verification of actual expiration dates.

The recalled product

Product
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Pancreatic Stent
Hazard
  • mislabeling

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: M84963520 Lot Numbers: H04-18-014R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category