Z-1067-2014Class II

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

Name: Z-1067-2014 Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Creator: Smith & Nephew Inc.
Published: 2013-11-14
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-11-14 / Terminated / root cause: design

FDA source

Smith & Nephew Inc. began a recall of Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System on 2013-11-14. FDA classified it as Class II and gives the reason as "Modification of the bacterial overflow guard (filter) and related changes to product labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1067-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-14
Posted: 2014-02-21
Terminated: 2014-08-04
Recalling firm: Smith & Nephew, Inc.
Product: Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Root cause tag: design
FDA root cause: Device Design
Action: 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..
Quantity in commerce: 6,799,140 canisters EZ & EZ PLUS
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, 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1067-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1067-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21
Z-1068-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21

Product code OMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)