Recalls / —

—#124059

Product

Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

FDA product code

OMP — Negative Pressure Wound Therapy Powered Suction Pump

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Product code:  66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299

Why it was recalled

Modification of the bacterial overflow guard (filter) and related changes to product labeling.

Root cause (FDA determination)

Device Design

Action the firm took

The correction strategy is as follows: " An Urgent Medical Device Correction Notice has been prepared to be distributed to all US consignees via Federal Express delivery for confirmation of the delivery. " A copy of the Urgent Medical Device Correction Notice is to be posted on Smith & Nephew's websites, URL corporate, http://www.smith-nephew.com/news-and-media/, and myrenasys.com, concurrent with the distribution of the Notice to consignees. " US distribution of the original design of Canister Kits codes (66800912, 66800913, 66801066, 66800423 and 66800058) subject to this correction ceased November 1, 2013. " The correction has been implemented on a change being affected basis. The modified design is being distributed to US customers effective November 1, 2013. No product will be removed from the market. " Periodic progress reports to FDA, as required per 21 CFR 806 will be submitted monthly until completion of the correction actions..

Recalling firm

Firm

Smith & Nephew Inc.

Address

970 Lake Carillon Dr, Ste 110, Saint Petersburg, Florida 33716-1130

Distribution

Distribution pattern

Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.

Timeline

Recall initiated

2013-11-14

Posted by FDA

2014-02-21

Terminated

2014-08-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #124059. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.