Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Number/CFN: OMS-T10BTS; UDI/DI: 20884521081076, 10884521081079; Lot Serial Number: P1D1416, P1E1509, P1F1547, P1H0898, P1J0874, P1J0895, P1J0895, P1J1268, P1J1268, P1J1340, P1J1340, P1J1341, P1K0181, P1L0683, P1L0978, P1L0984, P1L0984, P2A0017, P2A0017, P2A0018, P2A0019, P2A0019, P2A0020, P2A0021, P2A0021, P2A0750, P2A0750, P2B0135, P2B0136, P2B0136, P2B0752, P2B0916, P2C0757, P2D0347, P2D0541, P2D0542, P2F0385, P2F0386, P2F0386, P2H0022, P2H0022, P2H0147, P2H0147, P2K0433, P2K0433, P2K0434, P2K0434, P3D0123, P3D0123, P3D0124, P3D0124, P3E0187, P3E0187, P3E0188, P3E0189, P3E0189, P3H1197, P3J0771, P3J0858, P3K1341;
- 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" Blunt Tip Trocar, Product Number OMS-T10BTS
Product Codes/Lot Numbers:
Product Number/CFN: OMS-T10BTS; UDI/DI: 20884521081076, 10884521081079; Lot Serial Number: P1D1416, P1E1509, P1F1547, P1H0898, P1J0874, P1J0895, P1J0895, P1J1268, P1J1268, P1J1340, P1J1340, P1J1341, P1K0181, P1L0683, P1L0978, P1L0984, P1L0984, P2A0017, P2A0017, P2A0018, P2A0019, P2A0019, P2A0020, P2A0021, P2A0021, P2A0750, P2A0750, P2B0135, P2B0136, P2B0136, P2B0752, P2B0916, P2C0757, P2D0347, P2D0541, P2D0542, P2F0385, P2F0386, P2F0386, P2H0022, P2H0022, P2H0147, P2H0147, P2K0433, P2K0433, P2K0434, P2K0434, P3D0123, P3D0123, P3D0124, P3D0124, P3E0187, P3E0187, P3E0188, P3E0189, P3E0189, P3H1197, P3J0771, P3J0858, P3K1341;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1469-2024
Related Recalls
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
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