Recall Z-2638-2010 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2: Latex Free, Rx only. Integra LifeSciences (Ireland) Limited County Offaly, Ireland Distributed by Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536.
| Date | Sep 30, 2010 (initiated Jul 29, 2010) |
| Status | Terminated |
| Reason | A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the CUSA NXT Service module to run at maximum speed, and continue to run until the entire system is turned off. This may result in excess aspiration that requires medical intervention. |
| Root cause | Device Design |
| Action | Integra issued Urgent: Product Recall Notification letters dated July 29, 2010 to all customers on July 29, 2010 identifying the affected products, issue prompting the recall, and actions to be taken by the customer. Letters were also forwarded to all Integra Account Reps. Customers were advised to discontinue use of and quarantine the affected service modules. The Surgical Aspirator may be operated without the Service Module, utilizing the hospitals wall aspiration. Company representatives will contact customers to arrange product return and repair of the affected service modules. Customers a |
| Quantity | 26 units in US, 8 in Europe, 1 in Asia (both types of units) |
| Distribution | Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM Integra Radionics, Inc., Aug 13, 2008 |