🔍 RecallPedia

Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

Class I - Dangerous
🏥 Medical Devices Recalled: December 22, 2023 Windstone Medical Packaging Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Windstone Medical Packaging, Inc.
Reason for Recall:
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: US, FL, IL, CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1079-2024

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