FDAFDA · Food and drugs·Recall number Z-1114-2023
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Published February 22, 2023 · Recall initiated: December 7, 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
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Nationwide
- Lot
- GTIN 40193489468510, Lot # 22HMD545
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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