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Terminated

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

FDA Recall Z-1828-2008 · Posted 2008-09-03

Recalling FirmMallinckrodt Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2008-04-14
Date Terminated2011-05-20
Product Quantity2546 pieces

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.

Firm 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].

Root Cause

Device Design

Distribution Pattern

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031339OPTIBOLUSMallinckrodt Inc., Liebel-Flarsheim Business · 2003-07-11K912944CT 8000 DIGITAL INJECTION SYSTEMMallinckrodt Group, Inc. · 1992-02-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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