🔍 RecallPedia

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.

Class I - Dangerous
🏥 Medical Devices Recalled: January 15, 2021 Medline Industries Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: S-O303000; Batch Numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831; Lot Number and/or Serial Number: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831.
  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:
Medline Industries Inc
Reason for Recall:
Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.

Product Codes/Lot Numbers:

Model Number: S-O303000; Batch Numbers: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831; Lot Number and/or Serial Number: 154950, 154590, 158668, 159370, 192532, 192891, 19365, 200831.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1135-2021

Related Recalls