BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
FDA Recall #Z-2251-2024 — Class I — June 12, 2024
Product Description
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Reason for Recall
Sterilization certificates could not be validated by the supplier
Recalling Firm
Synergetics Inc — O Fallon, MO
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
14 units
Distribution
US Nationwide
Code Information
UDI/DI 20841305107544, Lot Number P62764979R
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated