🔍 RecallPedia

Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.

Class I - Dangerous
🏥 Medical Devices Recalled: April 22, 2016 Natus Medical Incorporated Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Filter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522917, 2522918, 2522919, 2522920, 2522921, 2522922, 2522923, 2522924, 2522925, 2522926, 2522930, and 2522931.
  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:
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.

Product Codes/Lot Numbers:

Filter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522917, 2522918, 2522919, 2522920, 2522921, 2522922, 2522923, 2522924, 2522925, 2522926, 2522930, and 2522931.

Distribution:

Distributed in: US, AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, DC, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1878-2016

Related Recalls

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Natus Medical Incorporated

Class I - Dangerous

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