PlainRecalls
FDA Devices Moderate Class II Ongoing

RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns,

Reported: September 28, 2016 Initiated: July 21, 2016 #Z-2848-2016

Product Description

RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.

Reason for Recall

Sterility seal integrity failures on the Renasys Sterile Transparent Film

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
45,455 devices (in the USA)
Distribution
Nationwide Distribution to AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI, Hawaii, and Puerto Rico Argentina, Australia, Bermuda, Brazil, Brunai, Canada, Curacao, Germany, Great Britain, Hong Kong, Ireland, Jordan, Malaysia, New Zeland, Peru, Saudi Arabia, Serbia, Singapore, South Africa, SriLanka, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
Location
Saint Petersburg, FL

Frequently Asked Questions

What product was recalled?
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.. Recalled by Smith & Nephew, Inc.. Units affected: 45,455 devices (in the USA).
Why was this product recalled?
Sterility seal integrity failures on the Renasys Sterile Transparent Film
Which agency issued this recall?
This recall was issued by the FDA Devices on September 28, 2016. Severity: Moderate. Recall number: Z-2848-2016.