🔍 RecallPedia

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Class I - Dangerous
🏥 Medical Devices Recalled: November 28, 2023 Natus Medical Incorporated Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
  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:
Natus Medical Incorporated
Reason for Recall:
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Product Codes/Lot Numbers:

UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0634-2024

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