Recall Z-0041-2015— Smith & Nephew, Inc.

Name: FDA recall Z-0041-2015
Creator: U.S. Food and Drug Administration
Published: 2014-07-18

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2014-07-18, terminated 2015-08-05. It names 2 FDA 510(k) clearances: K102001, K082426. Product: RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).. Reason: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-18
Terminated: 2015-08-05
Firm location: Saint Petersburg, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K102001 — MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPYSmith & Nephew, Inc.·cleared 2010-08-06
K082426 — RENASYS EZSmith & Nephew, Inc.·cleared 2008-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

Reason for recall

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Data sourced from openFDA. This site is unofficial and independent of the FDA.