The Recall Desk
HighFDA (Devices)·Z-0047-2023·Announced 2022-10-19

Freeman Pancreatic Flexi-Stent Kit Recall: Incorrect Expiration Date Label

Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent Kits with incorrect expiration dates on labels, potentially allowing devices to be used beyond their actual safe shelf life. Affected units were distributed from March 2018 to 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 a Class II medical device recall with no reported illnesses or injuries. However, the incorrect expiration date labeling constitutes a risk-of-harm scenario where pancreatic stents could be used past their actual safe period, potentially compromising device integrity. The hazard is theoretical (no injury reported) but clinically significant for a critical-care medical device.

Plain-English summary

Hobbs Medical, Inc. is recalling the Freeman Pancreatic Flexi-Stent Kit (Catalog Number 6351) due to labeling errors on affected units.

The device labels display an incorrect expiration date that extends the product's stated shelf life beyond its actual safe period. This means the pancreatic stents could potentially be used beyond their actual expiration date, which may compromise device integrity and sterility.

The recall affects Freeman Pancreatic Flexi-Stent Kits distributed in the United States from March 25, 2018 to September 28, 2020. Affected devices have lot numbers ending in 'R' (UDI-DI: M84963510). The mislabeled expiration dates range from November 1, 2022 to September 1, 2025. The product was also distributed worldwide to Canada, Austria, Belgium, Finland, and Norway.

Healthcare facilities and medical professionals with affected units should immediately cease use of kits containing devices with lot numbers ending in 'R' and contact Hobbs Medical, Inc. for replacement or disposal guidance.

The recalled product

Product
Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Pancreatic Stent Kit
Hazard
  • expiration-mislabeling
  • device-integrity-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:M84963510 Lot Numbers: H12-16-175R

Distribution

Distributed nationwide across the United States.

Related recalls

Same category