FDA recall Z-2335-2024

MICROspecialties, Inc. · Class II · device

Product

Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:

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

MO

Key facts

Status
Ongoing
Initiation date
2024-06-05
Report date
2024-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Middletown, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2024