Aligned Medical Solutions recall: Sterility Concern
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, 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?
DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297
- Product
- Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1,528 units
- Distribution
- US: FL, IL, CA OUS: None
- Recall date
- February 28, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)