Surgical Devices/Covidien

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 6

Known Identifiers & Locations

FEI Numbers 1219930
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (6)

Recall # Product Description Initiation Date Status Action
Z-0392-2010 SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, product code Surg300; Operator Manual, product code OPMA. Reason: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. 2009-09-23 Terminated View Details
Z-0393-2010 Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular Stapler 29 mm Digital Loading Unit, product code CS29; Circular Stapler 33 mm Digital Loading Unit, product code CS33. Reason: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. 2009-09-23 Terminated View Details
Z-0394-2010 Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit, product code RALC30V; Right Angle Linear Cutter, 45 mm Digital Loading Unit, product code RALC45. Reason: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. 2009-09-23 Terminated View Details
Z-0395-2010 Remote Control Unit with Wire, product code RCW100. Reason: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. 2009-09-23 Terminated View Details
Z-0396-2010 Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4. Reason: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. 2009-09-23 Terminated View Details
Z-0397-2010 FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product code FS214RC; Manual Release for FlexShaft II & III, product code MR14. Reason: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient. 2009-09-23 Terminated View Details

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