—#129732

Product

RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

FDA product code: OMP — Negative Pressure Wound Therapy Powered Suction Pump
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K082426
Affected lot / code info: Model #'s 66800059, all lots since product launched 01/16/2009

Why it was recalled

Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.

Root cause (FDA determination)

No Marketing Application

Action the firm took

All RENASYS EZ Products will be removed from the field and customers will be transitioned to other product. On August 13, 2014 the firm sent an "Urgent- Medical Device Removal RENASYS EZ" notification via FedEx overnight asking that the use of the RENASYS EZ should be immediately discontinued and the device should be returned to Smith & Nephew. If you have questions, please reach out to your Customer Care representative or call 1-800-876-1261 Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 970 Lake Carillon Dr, Ste 110, Saint Petersburg, Florida 33716-1130

Distribution

Distribution pattern: Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.

Timeline

Recall initiated: 2014-08-13
Posted by FDA: 2014-09-23
Terminated: 2015-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129732. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.