Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
FDA Recall #Z-1081-2024 — Class I — December 22, 2023
Product Description
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Reason for Recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Recalling Firm
Windstone Medical Packaging, Inc. — Billings, MT
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
80 kits
Distribution
US: FL, IL, CA OUS: None
Code Information
UDI: B098AMS129470/ Lot #s: 192389 and 194805
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated