Z-1080-2024 Class I Ongoing
FDA device recall Z-1080-2024 was initiated by Windstone Medical Packaging, Inc. on December 22, 2023 and is designated Class I. Reason for recall: Sterility assurance for saline included in surgical kits cannot be guaranteed. The recall status is ongoing. Affected quantity: 128 kits.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- December 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 kits
Product Description
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Reason for Recall
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Distribution Pattern
US: FL, IL, CA OUS: None
Code Information
UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582