Hobbs Transbronchial Aspiration Needle Recalled for Incorrect Expiration Date
Hobbs Medical is recalling transbronchial aspiration needles with incorrect expiration dates on labels. The 18 affected units were distributed in the US, Canada, Austria, Belgium, Finland, and Norway 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 an FDA Class II medical device recall for a labeling defect on a sterile surgical instrument. The incorrect expiration date extends the shelf life beyond the device's validated sterility period, creating risk of use with compromised sterility. As a risk-of-harm product, this warrants a High severity rating.
Plain-English summary
Hobbs Medical, Inc. is recalling the Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe (Catalog Number 4620) due to a labeling defect affecting 18 units.
The device labels display an incorrect expiration date, which extends the indicated shelf life of the product. This discrepancy means affected devices may be used beyond their validated sterility assurance period.
Affected devices have lot numbers ending in 'R' (UDI-DI: M84946200, Lot H06-17-090R) and were distributed worldwide between March 25, 2018, and September 28, 2020. Distribution areas included the United States, Canada, Austria, Belgium, Finland, and Norway.
Healthcare facilities should check their inventory for affected devices by lot number. Any facility with affected devices should contact Hobbs Medical, Inc. for instructions on return, replacement, or proper disposal.
The recalled product
- Product
- Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device
- Hazard
- labeling-error
- sterility-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: M84946200 Lot Numbers: H06-17-090R
Distribution
Distributed nationwide across the United States.
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