FDA recall Z-2253-2024
Synergetics Inc · Class I · device
Product
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Reason for recall
Sterilization certificates could not be validated by the supplier
Distribution
US Nationwide
Key facts
- Status
- Ongoing
- Initiation date
- 2024-06-12
- Report date
- 2024-07-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- O Fallon, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2253-2024