The Recall Desk

FDA (Devices) recall action 75966

Smith & Nephew, Inc. recalled 2 products on 2017-01-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-01-25
Critical
0
Units
31,920

Why these products were recalled

Lack of 510k clearance for design modification.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2017-01-25

    Smith & Nephew RENASYS GO Power Supply Recalled for Regulatory Clearance

    Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy External Power Supply Units because they lack 510(k) clearance for a design modification.

    Product
    Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, 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
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-01-25

    Smith & Nephew RENASYS GO Wound Therapy Recall for Clearance Issue

    Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy devices because they lack 510(k) clearance for a design modification.

    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
    Category
    Distribution
    0 states