FDAFDA · Food and drugs·Recall number Z-3069-2024
CRANIOTOMY PACK, Pack Number DYNJ46552O
Published September 18, 2024 · Recall initiated: June 18, 2024
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
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US: TX, IL, CA
- Lot
- UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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