🔍 RecallPedia

Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200

Class I - Dangerous
🏥 Medical Devices Recalled: March 19, 2024 Medtronic Perfusion Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    a) Model Numbers: 31100, GTIN 20885074257116, Lot Numbers: 2023081208; b) Model Numbers: 31125, GTIN 20885074257406, lot Numbers: 2023041455, 202306C205; c) Model Numbers: 31200, GTIN 00885074257433, Lot Numbers: 2023040542; c) Model Numbers: 31200, GTIN 20885074257437, Lot Numbers: 2023040542, 2023041002, 202305C173
  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:
Medtronic Perfusion Systems
Reason for Recall:
Potential for unsealed sterile packing.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200

Product Codes/Lot Numbers:

a) Model Numbers: 31100, GTIN 20885074257116, Lot Numbers: 2023081208; b) Model Numbers: 31125, GTIN 20885074257406, lot Numbers: 2023041455, 202306C205; c) Model Numbers: 31200, GTIN 00885074257433, Lot Numbers: 2023040542; c) Model Numbers: 31200, GTIN 20885074257437, Lot Numbers: 2023040542, 2023041002, 202305C173

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1803-2024

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