FDA recall Z-2252-2024

Synergetics Inc · Class I · device

Product

BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, 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-2252-2024