FDA Device recall Z-1068-2014
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System by Smith And Nephew, citing modification of the bacterial overflow guard (filter) and related changes to product labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1068-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-14 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Reason
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Identifiers
| code_info | Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1068-2014%22
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