FDA recall Z-2334-2024

Product

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

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-2334-2024