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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 112 07 12 000
Date submitted: 7/30/2012
Manufacturer:Covidien
Device Type:Shiley Reusable Cannula Low-Pressure Cuffed Tracheostomy Tubes
Description:Tracheostomy Tubes,mechanical ventilation
Medical Device Identifier: (1)8FEN Starting Lot Number: 0910000342 Ending Lot Number: 1101001558 Starting Lot Number: 110201893X Ending Lot Number: 120600700X (2)8LPC Starting Lot Number: 0910000346 Ending Lot Number: 1101001823 Starting Lot Number: 110200327X Ending Lot Number: 120600351X (for more code see attached)
Reason of Field Safety Corrective Action: Cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. These events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. If a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement
Remedy Action: Please review your inventory and immediately quarantine affected product codes and lot numbers, shown in the table below. Unused products from the affected product codes and lots should be returned as described below. If one of the recalled tubes is already in use in a patient, we recommend that the tube be replaced as soon as clinically appropriate, as determined by the patient’s physician. If the physician advises leaving the tracheostomy tube in place, we strongly encourage that the frequency of direct patient observation be increased.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:1060A9A6B7276
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Covidien.pdf