Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imagin
FDA device recall Z-1828-2008 · posted 2008-09-03 · Terminated
Recall details
- Recalling firm
- Mallinckrodt Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 2546 pieces
- 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
- Date initiated
- 2008-04-14
- Date posted
- 2008-09-03
- Date terminated
- 2011-05-20
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIBOLUS (K031339) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2003-07-11 |
| CT 8000 DIGITAL INJECTION SYSTEM (K912944) | Mallinckrodt Group, Inc. | 1992-02-04 |