FDAFDA · Food and drugs·Recall number Z-0014-2023
Hobbs Medical Cytology Brush Catalog Number: 4206
Published October 19, 2022 · Recall initiated: July 29, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hobbs Medical, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
- Lot
- UDI-DI:M84942060 Lot Numbers: H01-20-179R H01-20-181R H01-20-182R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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