BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intr...
FDA Recall #Z-2254-2024 — Class I — June 12, 2024
Product Description
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
Recalling Firm
Synergetics Inc — O Fallon, MO
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
35 units
Distribution
US Nationwide
Code Information
UDI/DI 20841305107612, Lot Number P62764970R
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated