Z-2336-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2024
- Initiation Date
- June 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 804 units
Product Description
Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
Reason for Recall
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Distribution Pattern
MO
Code Information
UDI: 10841305101132 LOT: P62764970R