Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL

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-T10BTNL; UDI/DI: 20884521527383, 10884521527386; Lot Serial Number: P0L1440, P0L1441, P0M1916, P0M1916, P0M1941, P1A1541, P1A1541, P1C0413, P1C0413, P1C0414, P1C0414, P1C0415, P1C0415, P1C1569, P1C1570, P1C1669, P1C1669, P1C1670, P1C1670, P1C1671, P1C1672, P1C1792, P1C1793, P1C1793, P1C1921, P1C1922, P1C1923, P1D0373, P1D0373, P1D0374, P1D0374, P1D0398, P1D1350, P1D1351, P1D1351, P1D1352, P1D1413, P1D1414, P1D1422, P1D1423, P1D1423, P1D1424, P1D1510, P1D1511, P1D1511, P1E1311, P1E1379, P1E1379, P1E1380, P1E1381, P1E1382, P1E1382, P1E1383, P1E1383, P1E1507, P1E1508, P1F1020, P1F1020, P1F1021, P1F1021, P1F1022, P1F1390, P1F1390, P1F1522, P1F1522, P1F1523, P1F1524, P1G0146, P1G0146, P1G0158, P1G0158, P1G0159, P1G1114, P1G1115, P1G1116, P1G1116, P1G1122, P1G1133, P1G1134, P1G1366, P1G1367, P1H0054, P1H0054, P1H0055, P1H0056, P1H0057, P1H1296, P1H1296, P1H1297, P1H1298, P1H1298, P1J0662, P1J0664, P1J0664, P1J0727, P1J0727, P1J0896, P1J0896, P1J1260, P1J1260, P1J1261, P1J1261, P1J1273, P1J1274, P1J1344, P1J1345, P1K0354, P1K0354, P1K0355, P1K0359, P1K0359, P1K0456, P1K0456, P1K0471, P1K0471, P1K0507, P1K0507, P1L0924, P1L0925, P1M0061, P1M0062, P1M0063, P1M0067, P1M0067, P1M0068, P1M0635, P1M0636, P1M0835, P1M0837, P1M0967, P1M0968, P2A0013, P2A0014, P2A0015, P2A0016, P2A0609, P2A0610, P2A0780, P2B0134, P2B0134, P2B0534, P2B0535, P2B0535, P2B0564, P2B0564, P2B0566, P2B0566, P2B0748, P2B0748, P2B0749, P2B0988, P2C0184, P2C0184, P2C0185, P2C0186, P2C0225, P2C0225, P2C0226, P2C0226, P2C0227, P2C0227, P2C0228, P2C0228, P2C0684, P2C0766, P2C0766, P2C0767, P2C0768, P2C0880, P2C0881, P2D0034, P2D0034, P2D0035, P2D0035, P2D0036, P2D0036, P2D0037, P2D0348, P2D0348, P2D0349, P2D0733, P2D0734, P2D0735, P2F0140, P2F0141, P2F0487, P2F0495, P2F0496, P2F0496, P2F0497, P2F0498, P2F0499, P2F0499, P2G0266, P2G0534, P2G0534, P2G0535, P2G0535, P2H0040, P2H0040, P2H0041, P2H0042, P2H0042, P2H0043, P2H0043, P2H0143, P2H0143, P2H0144, P2H0144, P2H0145, P2H0146, P2H0146, P2H0412, P2H0412, P2H0413, P2H0425, P2H0426, P2H0426, P2H0582, P2H0585, P2H0586, P2J0026, P2J0027, P2J0028, P2J0028, P2J0029, P2J0030, P2J0030, P2J0084, P2J0084, P2J0085, P2J0085, P2J0086, P2J0287, P2J0287, P2J0288, P2J0330, P2J0330, P2J0444, P2J0444, P2J0445, P2J0451, P2J0451, P2J0452, P2J0453, P2J0453, P2J0454, P2K0129, P2K0129, P2K0130, P2K0130, P2K0150, P2K0381, P2K0382, P2K0383, P2K0436, P2K0437, P2K0438, P2K0439, P2K0445, P2K0445, P2K0446, P2K0446, P2K0568, P2K0568, P2K0569, P2L0094, P2L0099, P2L0100, P2L0108, P2L0264, P2L0268, P2L0416, P2L0416, P2L0417, P2L0417, P2L0418, P2L0420, P2L0421, P2L0422, P2L0423, P2L0423, P2L0424, P2L0424, P2L0425, P2L0426, P2M0028, P2M0029, P2M0030, P2M0275, P2M0421, P3A0206, P3A0241, P3A0241, P3A0242, P3B0042, P3B0042, P3B0072, P3B0232, P3B0233, P3B0233, P3B0234, P3B0309, P3B0310, P3B0440, P3B0440, P3B0441, P3B0442, P3B0518, P3B0519, P3C0315, P3C0316, P3C0342, P3C0475, P3C0476, P3C0477, P3C0516, P3C0517, P3D0252, P3D0252, P3D0253, P3D0345, P3D0345, P3D0346, P3D0346, P3D0347, P3D0347, P3D0348, P3D0348, P3E0372, P3F0070, P3F0071, P3F0072, P3F0247, P3F0247, P3F0248, P3F0574, P3F0574, P3F0575, P3F0575, P3H0832, P3H0833, P3H0834, P3H0835, P3H0835, P3H0836, P3H0837, P3H0837, P3H0838, P3H1101, P3H1102, P3H1103, P3H1103, P3H1174, P3H1175, P3H1176, P3J0866, P3J0867, P3J0867, P3J0947, P3J0947, P3J0948, P3J0948, P3K0949, P3K0950, P3K1064, P3K1064, P3K1065, P3K1065, P3K1260, P3K1260, P3K1261, P3K1355, P3K1356, P3K1356, P3K1357, P3K1358, P3K1358, P3L0675, P3L0891, P3L0892;
  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-T10BTNL

Product Codes/Lot Numbers:

Product Number/CFN: OMS-T10BTNL; UDI/DI: 20884521527383, 10884521527386; Lot Serial Number: P0L1440, P0L1441, P0M1916, P0M1916, P0M1941, P1A1541, P1A1541, P1C0413, P1C0413, P1C0414, P1C0414, P1C0415, P1C0415, P1C1569, P1C1570, P1C1669, P1C1669, P1C1670, P1C1670, P1C1671, P1C1672, P1C1792, P1C1793, P1C1793, P1C1921, P1C1922, P1C1923, P1D0373, P1D0373, P1D0374, P1D0374, P1D0398, P1D1350, P1D1351, P1D1351, P1D1352, P1D1413, P1D1414, P1D1422, P1D1423, P1D1423, P1D1424, P1D1510, P1D1511, P1D1511, P1E1311, P1E1379, P1E1379, P1E1380, P1E1381, P1E1382, P1E1382, P1E1383, P1E1383, P1E1507, P1E1508, P1F1020, P1F1020, P1F1021, P1F1021, P1F1022, P1F1390, P1F1390, P1F1522, P1F1522, P1F1523, P1F1524, P1G0146, P1G0146, P1G0158, P1G0158, P1G0159, P1G1114, P1G1115, P1G1116, P1G1116, P1G1122, P1G1133, P1G1134, P1G1366, P1G1367, P1H0054, P1H0054, P1H0055, P1H0056, P1H0057, P1H1296, P1H1296, P1H1297, P1H1298, P1H1298, P1J0662, P1J0664, P1J0664, P1J0727, P1J0727, P1J0896, P1J0896, P1J1260, P1J1260, P1J1261, P1J1261, P1J1273, P1J1274, P1J1344, P1J1345, P1K0354, P1K0354, P1K0355, P1K0359, P1K0359, P1K0456, P1K0456, P1K0471, P1K0471, P1K0507, P1K0507, P1L0924, P1L0925, P1M0061, P1M0062, P1M0063, P1M0067, P1M0067, P1M0068, P1M0635, P1M0636, P1M0835, P1M0837, P1M0967, P1M0968, P2A0013, P2A0014, P2A0015, P2A0016, P2A0609, P2A0610, P2A0780, P2B0134, P2B0134, P2B0534, P2B0535, P2B0535, P2B0564, P2B0564, P2B0566, P2B0566, P2B0748, P2B0748, P2B0749, P2B0988, P2C0184, P2C0184, P2C0185, P2C0186, P2C0225, P2C0225, P2C0226, P2C0226, P2C0227, P2C0227, P2C0228, P2C0228, P2C0684, P2C0766, P2C0766, P2C0767, P2C0768, P2C0880, P2C0881, P2D0034, P2D0034, P2D0035, P2D0035, P2D0036, P2D0036, P2D0037, P2D0348, P2D0348, P2D0349, P2D0733, P2D0734, P2D0735, P2F0140, P2F0141, P2F0487, P2F0495, P2F0496, P2F0496, P2F0497, P2F0498, P2F0499, P2F0499, P2G0266, P2G0534, P2G0534, P2G0535, P2G0535, P2H0040, P2H0040, P2H0041, P2H0042, P2H0042, P2H0043, P2H0043, P2H0143, P2H0143, P2H0144, P2H0144, P2H0145, P2H0146, P2H0146, P2H0412, P2H0412, P2H0413, P2H0425, P2H0426, P2H0426, P2H0582, P2H0585, P2H0586, P2J0026, P2J0027, P2J0028, P2J0028, P2J0029, P2J0030, P2J0030, P2J0084, P2J0084, P2J0085, P2J0085, P2J0086, P2J0287, P2J0287, P2J0288, P2J0330, P2J0330, P2J0444, P2J0444, P2J0445, P2J0451, P2J0451, P2J0452, P2J0453, P2J0453, P2J0454, P2K0129, P2K0129, P2K0130, P2K0130, P2K0150, P2K0381, P2K0382, P2K0383, P2K0436, P2K0437, P2K0438, P2K0439, P2K0445, P2K0445, P2K0446, P2K0446, P2K0568, P2K0568, P2K0569, P2L0094, P2L0099, P2L0100, P2L0108, P2L0264, P2L0268, P2L0416, P2L0416, P2L0417, P2L0417, P2L0418, P2L0420, P2L0421, P2L0422, P2L0423, P2L0423, P2L0424, P2L0424, P2L0425, P2L0426, P2M0028, P2M0029, P2M0030, P2M0275, P2M0421, P3A0206, P3A0241, P3A0241, P3A0242, P3B0042, P3B0042, P3B0072, P3B0232, P3B0233, P3B0233, P3B0234, P3B0309, P3B0310, P3B0440, P3B0440, P3B0441, P3B0442, P3B0518, P3B0519, P3C0315, P3C0316, P3C0342, P3C0475, P3C0476, P3C0477, P3C0516, P3C0517, P3D0252, P3D0252, P3D0253, P3D0345, P3D0345, P3D0346, P3D0346, P3D0347, P3D0347, P3D0348, P3D0348, P3E0372, P3F0070, P3F0071, P3F0072, P3F0247, P3F0247, P3F0248, P3F0574, P3F0574, P3F0575, P3F0575, P3H0832, P3H0833, P3H0834, P3H0835, P3H0835, P3H0836, P3H0837, P3H0837, P3H0838, P3H1101, P3H1102, P3H1103, P3H1103, P3H1174, P3H1175, P3H1176, P3J0866, P3J0867, P3J0867, P3J0947, P3J0947, P3J0948, P3J0948, P3K0949, P3K0950, P3K1064, P3K1064, P3K1065, P3K1065, P3K1260, P3K1260, P3K1261, P3K1355, P3K1356, P3K1356, P3K1357, P3K1358, P3K1358, P3L0675, P3L0891, P3L0892;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1466-2024

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