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

FDA device recall Z-1068-2014 · posted 2014-02-21 · Terminated

Recall details

Recalling firm

Smith & Nephew Inc.

Reason for recall

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

Action taken

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..

Root cause

Device Design

Status

Terminated

Product code

OMP

Quantity affected

6,871,375 canisters

Distribution

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, an

Date initiated

2013-11-14

Date posted

2014-02-21

Date terminated

2014-08-04

Location

Saint Petersburg, FL