Recall Z-1041-2017— Smith & Nephew, Inc.

Name: FDA recall Z-1041-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-11

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-11-11. It names one FDA 510(k) clearance: K083375. Product: Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.. Reason: Lack of 510k clearance for design modification..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2016-11-11
Firm location: Saint Petersburg, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K083375 — RENASYS GO NEGATIVE PRESSURE WOUND THERAPYSmith & Nephew, Inc.·cleared 2009-02-25

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

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

Reason for recall

Lack of 510k clearance for design modification.

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