Recall Z-2688-2014— Smith & Nephew, Inc.

Name: FDA recall Z-2688-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-13

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2014-08-13, terminated 2015-08-06. It names one FDA 510(k) clearance: K082426. 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.. Reason: Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-13
Terminated: 2015-08-06
Firm location: Saint Petersburg, FL, United States

510(k) clearances named in this recall

1 on FDA's record

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 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.

Reason for recall

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

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