Z-1042-2017 Class II Ongoing
FDA device recall Z-1042-2017 was initiated by Smith & Nephew, Inc. on Nov 11, 2016 and is designated Class II. Reason for recall: Lack of 510k clearance for design modification. The recall status is ongoing. Affected quantity: 15,960 units (US ).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2017
- Initiation Date
- Nov 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,960 units (US )
Product Description
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 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.
Distribution Pattern
Nationwide
Code Information
Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1042-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026