Recall Z-1067-2014— Smith & Nephew Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew Inc., initiated 2013-11-14, terminated 2014-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Renasys EZ, 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..
- Recalling firm
- Smith & Nephew Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-14
- Terminated
- 2014-08-04
- Firm location
- Saint Petersburg, FL, United States
Product description
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Reason for recall
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Data sourced from openFDA. This site is unofficial and independent of the FDA.