Smith & Nephew, Inc. recalls RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film I…

Recall date

July 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2848-2016

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

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,…

Why it was recalled

Sterility seal integrity failures on the Renasys Sterile Transparent Film

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.