FDA recall Z-2254-2024

Product

BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, 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-2254-2024