Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

Class I - Dangerous
🏥 Medical Devices Recalled: February 28, 2024 Covidien Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Number/CFN: OMS-T12BT; UDI/DI: 20884521081090, 10884521081093; Lot Serial Number: P1C1924, P1D0400, P1D0400, P1D1411, P1D1412, P1D1508, P1F1483, P1F1484, P1F1484, P1F1485, P1F1485, P1F1591, P1G0141, P1G0141, P1G1118, P1G1120, P1H0046, P1H0046, P1H0047, P1H0047, P1H0048, P1H0048, P1H0861, P1H0861, P1H0862, P1H0862, P1J0858, P1J0858, P1J0860, P1J0860, P1K0455, P1K0455, P1K0838, P1K1052, P1L0926, P1L0926, P1L0985, P1M0026, P1M0026, P1M0027, P1M0027, P1M0028, P1M0028, P1M0031, P1M0031, P1M0743, P1M0743, P2A0129, P2A0744, P2A0744, P2A0745, P2B0746, P2B0746, P2C0176, P2C0176, P2C0177, P2C0177, P2C0230, P2C0230, P2C0231, P2C0231, P2C0232, P2C0232, P2C0233, P2C0233, P2C0879, P2C0879, P2D0512, P2D0512, P2E0351, P2E0351, P2E0370Q, P2E0664, P2E0664, P2F0486, P2F0486, P2G0305, P2G0305, P2H0086, P2H0086, P2H0087, P2H0148, P2H0148, P2H0308, P2H0409, P2H0415, P2H0415, P2H0579, P2H0579, P2J0008, P2J0008, P2J0082, P2J0082, P2J0458, P2J0459, P2J0459, P2K0081, P2K0081, P2K0124, P2K0124, P2K0435, P2K0435, P2K0566, P2K0566, P2L0565, P2M0162, P2M0163, P2M0163, P2M0164, P2M0164, P2M0269, P2M0269, P2M0270, P2M0270, P2M0271, P2M0271, P2M0274, P2M0274, P3A0164, P3A0164, P3B0074, P3B0263Q, P3B0263Q, P3D0154, P3D0154, P3D0155, P3D0155, P3D0247, P3D0247, P3D0248, P3D0248, P3D0249, P3D0249, P3D0402, P3E0244, P3E0244, P3E0245, P3E0245, P3F0571, P3F0572, P3F0572, P3G0180, P3G0180, P3G0331, P3G0331, P3G0332, P3G0332, P3H0760, P3H0760, P3H0763, P3H0763, P3H0764, P3H1058, P3J1104, P3J1104, P3J1165, P3K1277Q, P3L0884;
  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:
Covidien, LP
Reason for Recall:
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

Product Codes/Lot Numbers:

Product Number/CFN: OMS-T12BT; UDI/DI: 20884521081090, 10884521081093; Lot Serial Number: P1C1924, P1D0400, P1D0400, P1D1411, P1D1412, P1D1508, P1F1483, P1F1484, P1F1484, P1F1485, P1F1485, P1F1591, P1G0141, P1G0141, P1G1118, P1G1120, P1H0046, P1H0046, P1H0047, P1H0047, P1H0048, P1H0048, P1H0861, P1H0861, P1H0862, P1H0862, P1J0858, P1J0858, P1J0860, P1J0860, P1K0455, P1K0455, P1K0838, P1K1052, P1L0926, P1L0926, P1L0985, P1M0026, P1M0026, P1M0027, P1M0027, P1M0028, P1M0028, P1M0031, P1M0031, P1M0743, P1M0743, P2A0129, P2A0744, P2A0744, P2A0745, P2B0746, P2B0746, P2C0176, P2C0176, P2C0177, P2C0177, P2C0230, P2C0230, P2C0231, P2C0231, P2C0232, P2C0232, P2C0233, P2C0233, P2C0879, P2C0879, P2D0512, P2D0512, P2E0351, P2E0351, P2E0370Q, P2E0664, P2E0664, P2F0486, P2F0486, P2G0305, P2G0305, P2H0086, P2H0086, P2H0087, P2H0148, P2H0148, P2H0308, P2H0409, P2H0415, P2H0415, P2H0579, P2H0579, P2J0008, P2J0008, P2J0082, P2J0082, P2J0458, P2J0459, P2J0459, P2K0081, P2K0081, P2K0124, P2K0124, P2K0435, P2K0435, P2K0566, P2K0566, P2L0565, P2M0162, P2M0163, P2M0163, P2M0164, P2M0164, P2M0269, P2M0269, P2M0270, P2M0270, P2M0271, P2M0271, P2M0274, P2M0274, P3A0164, P3A0164, P3B0074, P3B0263Q, P3B0263Q, P3D0154, P3D0154, P3D0155, P3D0155, P3D0247, P3D0247, P3D0248, P3D0248, P3D0249, P3D0249, P3D0402, P3E0244, P3E0244, P3E0245, P3E0245, P3F0571, P3F0572, P3F0572, P3G0180, P3G0180, P3G0331, P3G0331, P3G0332, P3G0332, P3H0760, P3H0760, P3H0763, P3H0763, P3H0764, P3H1058, P3J1104, P3J1104, P3J1165, P3K1277Q, P3L0884;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1468-2024

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