Recall Z-1694-2008
Mallinckrodt Inc · initiated April 7, 2008
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.
Codes / lots: Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079
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: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1694-2008
- Initiated
- April 7, 2008
- Posted by FDA
- August 15, 2008
- Terminated
- May 20, 2011
- Product code
- IZQ – Injector, Contrast Medium, Automatic
- Quantity
- 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.
- Recalling firm
- Mallinckrodt Inc, Cincinnati, OH