Aligned Medical Solutions recall: Sterility Concern
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Why was Aligned Medical Solutions recalled?
Sterility assurance for saline included in surgical kits cannot be guaranteed.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: B098AMS129470/ Lot #s: 192389 and 194805
- Product
- Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 80 kits
- Distribution
- US: FL, IL, CA OUS: None
- Recall date
- February 28, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)