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U.S. Department of Health and Human Services

Class 2 Device Recall CT9000 & CT9000 ADV

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  Class 2 Device Recall CT9000 & CT9000 ADV see related information
Date Initiated by Firm April 14, 2008
Date Posted September 03, 2008
Recall Status1 Terminated 3 on May 20, 2011
Recall Number Z-1828-2008
Recall Event ID 47889
510(K)Number K031339  K912944  
Product Classification contrast media delivery system - Product Code DXT
Product Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
Code Information 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
Recalling Firm/
Manufacturer		 Mallinckrodt Inc
2111 E Galbraith Rd
Cincinnati OH 45237-1624
For Additional Information Contact Dale Moore
513-948-5771
Manufacturer 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.
FDA Determined
Cause 2		 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 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MALLINCKRODT GROUP, INC.
510(K)s with Product Code = DXT and Original Applicant = MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
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