🔍 RecallPedia

Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿

Class I - Dangerous
🏥 Medical Devices Recalled: September 5, 2017 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model # HCS00350 Lot Numbers: ¿A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554
  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:
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Reason for Recall:
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿

Product Codes/Lot Numbers:

Model # HCS00350 Lot Numbers: ¿A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0718-2019

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