🔍 RecallPedia

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT

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-T10BT; UDI/DI: 10884521080874, 20884521080871; Lot Serial Number: P1D1353, P1D1353, P1D1355, P1D1409, P1D1410, P1D1506, P1D1506, P1D1507, P1D1507, P1E1402, P1E1402, P1E1403, P1E1403, P1E1505, P1E1505, P1E1506, P1E1506, P1F0061, P1F0061, P1F0062, P1F0062, P1F0063, P1F1018, P1F1018, P1F1019, P1F1388, P1F1388, P1F1546, P1G0140, P1G0140, P1G1117, P1G1117, P1G1119, P1G1119, P1G1121, P1G1121, P1G1364, P1G1364, P1H0049, P1H0049, P1H0421, P1H0527Q, P1H0527Q, P1H0859, P1H0859, P1H0860, P1H0860, P1J1272, P1J1321, P1J1321, P1J1339, P1J1339, P1J1342, P1J1342, P1K0179, P1K0179, P1K0180, P1K0180, P1K0182, P1K0182, P1K0353, P1K0353, P1K0560, P1K0560, P1K0561, P1K0561, P1K0589, P1K0589, P1L0490, P1L0490, P1L0681, P1L0681, P1L0705, P1L0705, P1L0976, P1L0976, P1M0021, P1M0021, P1M0022, P1M0744, P1M0744, P1M0745, P1M0970, P1M0971, P1M1151, P1M1152, P2A0118, P2A0118, P2B0028Q, P2B0137, P2B0137, P2B0139, P2B0139, P2B0308, P2B0745, P2B0745, P2B0912, P2B0912, P2B0913, P2B0913, P2C0175, P2C0175, P2C0178, P2C0643, P2C0643, P2C0758, P2C0758, P2C0764, P2C0765, P2C0765, P2C0877, P2C0877, P2C0878, P2C0878, P2D0231, P2D0231, P2D0232, P2D0232, P2D0373, P2D0373, P2D0374, P2D0374, P2D0415, P2D0415, P2D0539, P2D0539, P2D0540, P2D0540, P2E0244, P2E0244, P2E0245, P2E0371, P2E0371, P2F0041, P2F0041, P2F0042, P2F0133, P2F0133, P2F0134, P2F0134, P2F0135, P2F0135, P2F0449, P2F0449, P2F0450, P2F0450, P2F0451, P2F0451, P2F0452, P2F0452, P2F0453, P2F0453, P2F0454, P2F0454, P2G0141Q, P2G0533, P2G0533, P2H0085, P2H0085, P2H0142, P2H0142, P2H0419, P2H0419, P2H0570, P2H0570, P2J0081, P2J0081, P2J0362, P2J0362, P2J0442, P2J0442, P2J0443, P2J0443, P2J0460, P2J0460, P2K0080, P2K0080, P2K0123, P2K0123, P2K0432, P2K0432, P2K0565, P2K0565, P2L0554, P2L0554, P2L0555, P2L0555, P2L0556, P2L0556, P2M0032, P2M0408, P2M0408, P2M0409, P2M0410, P2M0410, P2M0411, P2M0411, P3A0084, P3A0084, P3A0085, P3A0086, P3A0086, P3A0087, P3A0271, P3A0271, P3A0272, P3A0272, P3A0273, P3A0273, P3A0277, P3A0277, P3A0278, P3A0278, P3A0279, P3A0279, P3B0075, P3B0075, P3B0147, P3B0147, P3B0158, P3B0158, P3B0162Q, P3D0121, P3D0121, P3D0122, P3D0122, P3D0150, P3D0150, P3D0151, P3D0151, P3D0152, P3D0152, P3D0399, P3D0400, P3D0400, P3D0401, P3D0401, P3E0294, P3E0294, P3E0295, P3E0295, P3E0315, P3E0315, P3E0369, P3E0369, P3F0461, P3F0461, P3F0462, P3F0462, P3H1033, P3H1033, P3H1034, P3H1193, P3H1193, P3H1194, P3H1194, P3H1195, P3H1195, P3J0855, P3J0855, P3J0856, P3J0857, P3J0857, P3J1100, P3J1100, P3J1101, P3J1101, P3J1102, P3J1103, P3J1103, P3K0951, P3K1067, P3K1068, P3K1069, P3K1243, P3K1244, P3K1339, P3K1340, P3L0889, P3L0890;
  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-T10BT

Product Codes/Lot Numbers:

Product Number/CFN: OMS-T10BT; UDI/DI: 10884521080874, 20884521080871; Lot Serial Number: P1D1353, P1D1353, P1D1355, P1D1409, P1D1410, P1D1506, P1D1506, P1D1507, P1D1507, P1E1402, P1E1402, P1E1403, P1E1403, P1E1505, P1E1505, P1E1506, P1E1506, P1F0061, P1F0061, P1F0062, P1F0062, P1F0063, P1F1018, P1F1018, P1F1019, P1F1388, P1F1388, P1F1546, P1G0140, P1G0140, P1G1117, P1G1117, P1G1119, P1G1119, P1G1121, P1G1121, P1G1364, P1G1364, P1H0049, P1H0049, P1H0421, P1H0527Q, P1H0527Q, P1H0859, P1H0859, P1H0860, P1H0860, P1J1272, P1J1321, P1J1321, P1J1339, P1J1339, P1J1342, P1J1342, P1K0179, P1K0179, P1K0180, P1K0180, P1K0182, P1K0182, P1K0353, P1K0353, P1K0560, P1K0560, P1K0561, P1K0561, P1K0589, P1K0589, P1L0490, P1L0490, P1L0681, P1L0681, P1L0705, P1L0705, P1L0976, P1L0976, P1M0021, P1M0021, P1M0022, P1M0744, P1M0744, P1M0745, P1M0970, P1M0971, P1M1151, P1M1152, P2A0118, P2A0118, P2B0028Q, P2B0137, P2B0137, P2B0139, P2B0139, P2B0308, P2B0745, P2B0745, P2B0912, P2B0912, P2B0913, P2B0913, P2C0175, P2C0175, P2C0178, P2C0643, P2C0643, P2C0758, P2C0758, P2C0764, P2C0765, P2C0765, P2C0877, P2C0877, P2C0878, P2C0878, P2D0231, P2D0231, P2D0232, P2D0232, P2D0373, P2D0373, P2D0374, P2D0374, P2D0415, P2D0415, P2D0539, P2D0539, P2D0540, P2D0540, P2E0244, P2E0244, P2E0245, P2E0371, P2E0371, P2F0041, P2F0041, P2F0042, P2F0133, P2F0133, P2F0134, P2F0134, P2F0135, P2F0135, P2F0449, P2F0449, P2F0450, P2F0450, P2F0451, P2F0451, P2F0452, P2F0452, P2F0453, P2F0453, P2F0454, P2F0454, P2G0141Q, P2G0533, P2G0533, P2H0085, P2H0085, P2H0142, P2H0142, P2H0419, P2H0419, P2H0570, P2H0570, P2J0081, P2J0081, P2J0362, P2J0362, P2J0442, P2J0442, P2J0443, P2J0443, P2J0460, P2J0460, P2K0080, P2K0080, P2K0123, P2K0123, P2K0432, P2K0432, P2K0565, P2K0565, P2L0554, P2L0554, P2L0555, P2L0555, P2L0556, P2L0556, P2M0032, P2M0408, P2M0408, P2M0409, P2M0410, P2M0410, P2M0411, P2M0411, P3A0084, P3A0084, P3A0085, P3A0086, P3A0086, P3A0087, P3A0271, P3A0271, P3A0272, P3A0272, P3A0273, P3A0273, P3A0277, P3A0277, P3A0278, P3A0278, P3A0279, P3A0279, P3B0075, P3B0075, P3B0147, P3B0147, P3B0158, P3B0158, P3B0162Q, P3D0121, P3D0121, P3D0122, P3D0122, P3D0150, P3D0150, P3D0151, P3D0151, P3D0152, P3D0152, P3D0399, P3D0400, P3D0400, P3D0401, P3D0401, P3E0294, P3E0294, P3E0295, P3E0295, P3E0315, P3E0315, P3E0369, P3E0369, P3F0461, P3F0461, P3F0462, P3F0462, P3H1033, P3H1033, P3H1034, P3H1193, P3H1193, P3H1194, P3H1194, P3H1195, P3H1195, P3J0855, P3J0855, P3J0856, P3J0857, P3J0857, P3J1100, P3J1100, P3J1101, P3J1101, P3J1102, P3J1103, P3J1103, P3K0951, P3K1067, P3K1068, P3K1069, P3K1243, P3K1244, P3K1339, P3K1340, P3L0889, P3L0890;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1470-2024

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Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN

Covidien

Class I - Dangerous

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

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