Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra LifeSciences (Ireland

FDA device recall Z-2637-2010 · posted 2010-09-30 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

LFL

Quantity affected

26 in US, 8 in Europe and 1 in Asia (both unit types.

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 Swit

Date initiated

2010-07-29

Date posted

2010-09-30

Date terminated

2012-05-15

Location

Plainsboro, NJ

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