🔍 RecallPedia

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Class I - Dangerous
🏥 Medical Devices Recalled: August 10, 2022 Saranas Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/REF/Lot: 00866532000402/FG001-01/510090S, 511110A, 510120F, 102422, 102445, 102531, 102671, 102685, 102731; 00866532000419/FG001-02/515070A, 528090C, 510120G, 511110B, 102567, 102610, 102611
  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:
Saranas, Inc.
Reason for Recall:
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Product Codes/Lot Numbers:

UDI/REF/Lot: 00866532000402/FG001-01/510090S, 511110A, 510120F, 102422, 102445, 102531, 102671, 102685, 102731; 00866532000419/FG001-02/515070A, 528090C, 510120G, 511110B, 102567, 102610, 102611

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1684-2022