FDA Recall Terminated

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.

Recall: Z-2638-2010 · Initiated July 29, 2010

Recall

Recall Number: Z-2638-2010
Event Number: 56463
Firm: Integra LifeSciences Corp.
FEI Number: 3003418325
Product Code: LFL
Status: Terminated
Root Cause: Device Design
Initiated: July 29, 2010
Posted: September 30, 2010
Terminated: May 15, 2012
Address: 311 Enterprise Dr, Plainsboro, NJ, 08536-3344

Description

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.

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 are to complete and return an enclosed Recall Acknowledgement and Return Form. The firm can be contacted at 609 936-2485.

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.

Quantity

26 units in US, 8 in Europe, 1 in Asia (both types of units)