Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
- Company
- Mallinckrodt Inc
- Recall Initiated
- April 14, 2008
- Posted
- September 3, 2008
- Terminated
- May 20, 2011
- Recall Number
- Z-1828-2008
- Quantity
- 2546 pieces
- Firm Location
- Cincinnati, OH
Reason for Recall
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.
Distribution
Product was sold in 46 US states: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV & WY,
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.