The Recall Desk
HighFDA (Devices)·Z-0018-2023·Announced 2022-10-19

Hobbs Medical Transbronchial Aspiration Needle Recalled for Incorrect Expiration Date

Hobbs Medical recalls Transbronchial Aspiration Needle (Catalog 4621) for incorrect expiration dates extending shelf life. Affected devices distributed in the US and internationally 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 recall of a medical device with an incorrect expiration date that extends shelf life, creating a potential risk of harm through device degradation on an invasive respiratory needle. No illnesses or injuries have been reported, which limits the score below 'Severe,' but the risk-of-harm nature of the product warrants a 'High' score.

Plain-English summary

Hobbs Medical, Inc. is recalling the Hobbs Transbronchial Aspiration Needle (Catalog Number 4621). The recalled devices have incorrect expiration dates printed on their labels, which extends the stated shelf life beyond the actual safe use period. This labeling error affects only devices with lot numbers ending in 'R' or kits containing at least one such device.

The affected devices were distributed worldwide, including throughout the United States and to Canada, Austria, Belgium, Finland, and Norway. Distribution occurred between March 25, 2018 and September 28, 2020. The incorrect expiration dates range from November 1, 2022 to September 1, 2025. Seven units are affected by this recall.

Healthcare facilities and medical professionals using these devices should verify the lot numbers of any Hobbs Transbronchial Aspiration Needles in their inventory. If a device has a lot number ending in 'R' or is a kit containing such a device, it should not be used. Users should contact Hobbs Medical, Inc. for instructions on proper handling and replacement of affected devices.

The recalled product

Product
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Manufacturer
Hobbs Medical, Inc.
Category
Medical Device — Respiratory Needle
Hazard
  • incorrect-expiration-date
  • extended-shelf-life

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:M84946210 Lot Numbers: H04-17-039R

Distribution

Distributed nationwide across the United States.

Related recalls

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