—#93734

Product

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.

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K081459
Affected lot / code info: Serial numbers: NXT1022, NXT1023, NXT1026, NXT1043, NXT1050, NXT1051, NXT1056, NXT1057, NXT1008, NXT1018, NXT1019, NXT1029, NXT1030, NXT1042, NXT1062, NXT1063, NXT1064, NXT1067, NXT1069, NXT1070, NBC1001901IE.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-07-29
Posted by FDA: 2010-09-30
Terminated: 2012-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93734. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.