🔍 RecallPedia

98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set.

Class I - Dangerous
🏥 Medical Devices Recalled: July 6, 2020 ICU Medical Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number:4584862.
  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:
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set.

Product Codes/Lot Numbers:

Lot Number:4584862.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0257-2021

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