Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Number/CFN: OMS-T10SB; UDI/DI: 20884521081083 and 10884521081086; Lot Serial Number: P0B1097Y, P0L1408, P0L1408, P0L1442, P0L1442, P0M1720, P0M1721, P0M1931, P1A1469, P1A1469, P1A1470, P1A1485, P1A1486, P1A1486, P1B1294, P1B1294, P1B1449, P1C0441, P1C1565, P1C1565, P1C1566, P1C1568, P1C1674, P1C1674, P1C1675, P1C1676, P1C1676, P1C1786, P1C1920, P1D0366, P1D1379, P1D1379, P1D1380, P1D1380, P1D1509, P1D1509, P1E1551, P1F1389, P1F1482, P1F1482, P1F1521, P1G0143, P1G0143, P1K0808, P1K0808, P1K1036, P1K1099, P1K1099, P1K1320, P1L0482, P1L0482, P1L0486, P1L0486, P1L0679, P1L0679, P1L0680, P1L0680, P1L0885, P1L0885, P1L1108, P1L1109, P1L1109, P1M0032, P1M0032, P1M0033, P1M0033, P2A0611, P2A0611, P2A0612, P2A0612, P2A0613, P2A0613, P2A0614, P2A0615, P2A0615, P2B0280, P2B0280, P2C0455, P2C0456, P2C0457, P2C0745, P2C0745, P2D0324, P2D0325, P2D0325, P2D0326, P2D0327, P2D0352, P2D0352, P2D0353, P2D0353, P2E0013, P2E0013, P2E0014, P2E0014, P2E0076, P2E0077, P2E0077, P2E0078, P2E0352, P2E0447, P2E0448, P2E0449, P2E0449, P2F0136, P2F0136, P2F0137, P2F0137, P2F0138, P2F0139, P2F0139, P2F0384, P2F0384, P2F0455, P2F0455, P2F0456, P2F0456, P2F0457, P2F0457, P2G0324, P2G0324, P2H0044, P2H0273, P2H0307, P2H0414, P2J0025, P2J0083, P2J0286, P2J0455, P2K0149, P2K0440, P2L0090, P2L0091, P2L0091, P2M0031, P3A0237, P3A0238, P3A0239, P3A0240, P3A0240, P3B0308, P3B0443, P3B0444, P3B0444, P3D0349, P3D0350, P3D0350, P3E0080, P3E0080, P3E0371, P3E0458, P3E0458, P3F0043, P3F0043, P3F0044, P3H0831, P3H1177, P3H1177, P3J0865, P3J0865, P3J0944, P3J0944, P3J0945, P3J0945, P3J0946, P3J1063, P3J1064, P3J1131, P3L0678, P3L0679, P3L0820, P3L0821;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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" Structural Balloon Trocar, Product Number OMS-T10SB
Product Codes/Lot Numbers:
Product Number/CFN: OMS-T10SB; UDI/DI: 20884521081083 and 10884521081086; Lot Serial Number: P0B1097Y, P0L1408, P0L1408, P0L1442, P0L1442, P0M1720, P0M1721, P0M1931, P1A1469, P1A1469, P1A1470, P1A1485, P1A1486, P1A1486, P1B1294, P1B1294, P1B1449, P1C0441, P1C1565, P1C1565, P1C1566, P1C1568, P1C1674, P1C1674, P1C1675, P1C1676, P1C1676, P1C1786, P1C1920, P1D0366, P1D1379, P1D1379, P1D1380, P1D1380, P1D1509, P1D1509, P1E1551, P1F1389, P1F1482, P1F1482, P1F1521, P1G0143, P1G0143, P1K0808, P1K0808, P1K1036, P1K1099, P1K1099, P1K1320, P1L0482, P1L0482, P1L0486, P1L0486, P1L0679, P1L0679, P1L0680, P1L0680, P1L0885, P1L0885, P1L1108, P1L1109, P1L1109, P1M0032, P1M0032, P1M0033, P1M0033, P2A0611, P2A0611, P2A0612, P2A0612, P2A0613, P2A0613, P2A0614, P2A0615, P2A0615, P2B0280, P2B0280, P2C0455, P2C0456, P2C0457, P2C0745, P2C0745, P2D0324, P2D0325, P2D0325, P2D0326, P2D0327, P2D0352, P2D0352, P2D0353, P2D0353, P2E0013, P2E0013, P2E0014, P2E0014, P2E0076, P2E0077, P2E0077, P2E0078, P2E0352, P2E0447, P2E0448, P2E0449, P2E0449, P2F0136, P2F0136, P2F0137, P2F0137, P2F0138, P2F0139, P2F0139, P2F0384, P2F0384, P2F0455, P2F0455, P2F0456, P2F0456, P2F0457, P2F0457, P2G0324, P2G0324, P2H0044, P2H0273, P2H0307, P2H0414, P2J0025, P2J0083, P2J0286, P2J0455, P2K0149, P2K0440, P2L0090, P2L0091, P2L0091, P2M0031, P3A0237, P3A0238, P3A0239, P3A0240, P3A0240, P3B0308, P3B0443, P3B0444, P3B0444, P3D0349, P3D0350, P3D0350, P3E0080, P3E0080, P3E0371, P3E0458, P3E0458, P3F0043, P3F0043, P3F0044, P3H0831, P3H1177, P3H1177, P3J0865, P3J0865, P3J0944, P3J0944, P3J0945, P3J0945, P3J0946, P3J1063, P3J1064, P3J1131, P3L0678, P3L0679, P3L0820, P3L0821;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1465-2024
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