FDA Device

Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.

Hazard

The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.

What You Should Do

Remedy

Letter dated April 18, 2008. The firm has requested their customers check their inventory, and determine if they have any of the affected suspension systems. If they observe any loose screws or cracking around the J-Bow tube, immediately take the system out of service. A service representative will contact them to schedule any required system corrections. For assistance, contact Product Monitoring Department at 1-800-778-7898 or by email at productmonitoringhazelwood@covidien.com.

Products

Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
Brand
Mallinckrodt Inc
UPC
Model Number: 241300 is an accessory to a device. The device is catalog numbers 9021M, 9023M, ADV9021, ADV9021M, ADV9024M, ADVEL9021, ADVEL9021M, ADVEL9123, ADV9124M, ADVEL19021M, ADW9021, ADVI9021M, ADVI9023, ADVI9023M, ADW9024, ADWC9021, ADWC9021MOB, ADWC9023, ADWC9024, ADVUCI9021, ADWCI90210B, contrast media delivery system for diagnostic imaging, and contains the main injector PN'S 800001, 800003, 800005, 800006, 800007, 820003, 820004, 820005, 820006, 820007, 820014, 820016, 820035, 820036

Units Affected

2546 pieces