Z-2334-2024 Class II Ongoing
FDA device recall Z-2334-2024 was initiated by MICROspecialties, Inc. on June 5, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 96 units.
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
- 96 units
Product Description
Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
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: 10841305101071 LOT: P63044983R