🔍 RecallPedia

da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Class I - Dangerous
🏥 Medical Devices Recalled: March 16, 2015 Intuitive Surgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Product number 420258-01; da Vinci S Disposable Accessory Kit, 4 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D141015R, D142205, D142275, D142345, D142485, D142625, D142685, D142765, D142835, D142905, D142965, D143035, D143105, D143175, D143245, D143315, D143385, D143445, D143515, D150085, D150155, D150215, D150295, D150365, D150435, D150515, D150575, D150655
  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:
Intuitive Surgical, Inc.
Reason for Recall:
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Product Codes/Lot Numbers:

Product number 420258-01; da Vinci S Disposable Accessory Kit, 4 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D141015R, D142205, D142275, D142345, D142485, D142625, D142685, D142765, D142835, D142905, D142965, D143035, D143105, D143175, D143245, D143315, D143385, D143445, D143515, D150085, D150155, D150215, D150295, D150365, D150435, D150515, D150575, D150655

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1390-2015

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