FDA Medical Device Recalls (openFDA)
Mallinckrodt Inc: Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
- Recall number
- Z-1828-2008
- Recalling firm
- Mallinckrodt Inc
- Product
- Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
- Status
- Terminated
- Initiated
- 2008-04-14
- Posted
- 2008-09-03
- Terminated
- 2011-05-20
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 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, VA, WA, WI, WV & WY,
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K031339","K912944"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 1518293
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28