🔍 RecallPedia

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

Class I - Dangerous
🏥 Medical Devices Recalled: August 29, 2022 Intersurgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071
  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:
Intersurgical Inc
Reason for Recall:
Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

Product Codes/Lot Numbers:

UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

Distribution:

Distributed in: OH, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0096-2023

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