Hobbs Biliary Pigtail Stent Kits Recalled Due to Incorrect Expiration Date Label
Hobbs Medical is recalling Biliary Pigtail Stent Kits distributed from March 2018 to September 2020 due to incorrect expiration date labels that extend the shelf life beyond the actual safe period.
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: No adverse events have been reported. However, the mislabeled expiration date allows devices to be used beyond their actual safe period, presenting a risk of device failure or malfunction. This qualifies as a risk-of-harm product where injury has not yet been reported, per the FDA severity rubric.
Plain-English summary
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (Catalog Number: 6108) because the device labels display incorrect expiration dates. The labeled expiration dates extend the shelf life beyond the actual safe use period for the devices.
The affected devices were distributed in the United States from March 25, 2018 to September 28, 2020. Devices with lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R" are included in this recall. The lot number H02-18-254R is specifically identified.
Patients and healthcare providers with these stent kits should immediately discontinue use. Contact Hobbs Medical, Inc. with your device lot number for return instructions and guidance. Using devices beyond their actual safe expiration date could result in device failure or malfunction.
The recall affects devices distributed nationwide in the United States and internationally in Canada, Austria, Belgium, Finland, and Norway.
The recalled product
- Product
- Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Biliary Stent
- Hazard
- mis-labeling
- expired-device
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:M84961080 Lot Numbers: H02-18-254R
Distribution
Distributed nationwide across the United States.
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