Z-3069-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- June 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188 units
Product Description
CRANIOTOMY PACK, Pack Number DYNJ46552O
Reason for Recall
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.
Distribution Pattern
US: TX, IL, CA
Code Information
UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872