Z-1828-2008

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

Name: Z-1828-2008 Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for...
Creator: Mallinckrodt Inc
Published: 2008-04-14
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2008-04-14 / Terminated / root cause: design

FDA source

Mallinckrodt Inc began a recall of Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging on 2008-04-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1828-2008
Status: Terminated
Initiated: 2008-04-14
Posted: 2008-09-03
Terminated: 2011-05-20
Recalling firm: Mallinckrodt, Inc.
Product: Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
Product code: DXT Injector And Syringe, Angiographic
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.
Root cause tag: design
FDA 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 [email protected].
Quantity in commerce: 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,
Product codes and lots: 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

Product code DXT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)