The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media in
FDA device recall Z-1694-2008 · posted 2008-08-15 · Terminated
Recall details
- Recalling firm
- Mallinckrodt Inc
- 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.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IZQ
- Quantity affected
- 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
- Date initiated
- 2008-04-07
- Date posted
- 2008-08-15
- Date terminated
- 2011-05-20
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION (K063503) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007-04-27 |