🔍 RecallPedia

Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

Class I - Dangerous
🏥 Medical Devices Recalled: January 9, 2019 Karl Storz Endoscopy Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555
  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:
Karl Storz Endoscopy
Reason for Recall:
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10

Product Codes/Lot Numbers:

Model/Lot Number: 031200-10/Lot W-027781, W-029058, W-028738; 031322-10/ Lot W-027197, W-028171, W-027939, W-028207; 031532-10/ Lot W-026437, W-027332, W-026871; 031622-10/Lot W-029555

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1942-2020

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