Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.

Class I - Dangerous
🏥 Medical Devices Recalled: January 25, 2023 Stryker Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001
  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:
Stryker Corporation
Reason for Recall:
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.

Product Codes/Lot Numbers:

UDI-DI: 10859506006125 Lot Numbers: M2110004, M2201002, M2202001, M2203002, M2206001

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1184-2023

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