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U.S. Department of Health and Human Services

Class 2 Device Recall OptiVantage DH Injector Suspension System (JBow)

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  Class 2 Device Recall OptiVantage DH Injector Suspension System (JBow) see related information
Date Initiated by Firm April 07, 2008
Date Posted August 15, 2008
Recall Status1 Terminated 3 on May 20, 2011
Recall Number Z-1694-2008
Recall Event ID 47766
510(K)Number K063503  
Product Classification Angiographic Injector & Syringe - Product Code IZQ
Product The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.
Code Information Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079
Recalling Firm/
Manufacturer		 Mallinckrodt Inc
2111 E Galbraith Rd
Cincinnati OH 45237-1624
For Additional Information Contact Dale Moore
513-948-5719
Manufacturer Reason
for Recall		 Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.
FDA Determined
Cause 2		 Component design/selection
Action On April 18, 2008, Mallincrodt Inc. issued an Urgent Device Correction letter informing customers to check their inventory, and determine if they have any defective system units. If they observe any loose screws, sheared screws and/or elongated opening(s) around the screws, they are to immediately take the system out of service and contact the firm's service representative. Covidien's customers were all asked to inspect their inventories and to complete an 'Effectiveness Check Return Form' whether or not the product is defective. However, only those system units observed to have loose screws, sheared screws, and/or elongated openings around the screws, will be scheduled to receive correction by a Covidien Service Representative.
Quantity in Commerce 783 Units
Distribution Product is distributed in the US throughout the following states: AL, AR, AZ, CA, CO ,CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV.
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 = IZQ and Original Applicant = MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
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