🔍 RecallPedia

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

Class I - Dangerous
🏥 Medical Devices Recalled: July 29, 2019 ICU Medical Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Code: 163639255, Lot number 855735H, 866165H, 897465H, 907305H, 929285H, 929425H
  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:
ICU Medical Inc
Reason for Recall:
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

Product Codes/Lot Numbers:

Product Code: 163639255, Lot number 855735H, 866165H, 897465H, 907305H, 929285H, 929425H

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0144-2020

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