Recall Z-2848-2016— Smith & Nephew, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-07-21. It names 2 FDA 510(k) clearances: K142979, K061919. Product: 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: Sterility seal integrity failures on the Renasys Sterile Transparent Film.
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2016-07-21
- Firm location
- Saint Petersburg, FL, United States
510(k) clearances named in this recall
2 on FDA's recordK-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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.