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.

Sterility seal integrity failures on the Renasys Sterile Transparent Film

Smith & Nephew sent an Urgent Medical Device Removal Notice dated July 21, 2016, to all consignees informing them of a voluntary medical device recall involving Sterile RENASYS Transparent Film and the RENASYS Dressing Kits that contain the folded RENASYS Transparent Film. Smith & Nephew have identified that the process of folding the Sterile RENASYS" Transparent Film pouch during its packaging has the potential to damage the pouch seals resulting in a loss of sterility of the product. The loss of sterility has the potential to contribute to a local infection. Actions to be taken by customers and distributors: All affected Sterile RENASYS Transparent Film and the RENASYS Dressing Kits that contain the folded RENASYS Transparent Film must be returned to Smith & Nephew. For questions regarding this recall call 727-642-5849. Users must complete the Acknowledgment, Receipt and Confirmation of Return Form attached with this notice and return to [email protected]. This will trigger the return authorization process if you have product to return. An Acknowledgement, Receipt and Confirmation of Return Form must be returned even if you do not have any affected product in your inventory. Device users are reminded that reports of adverse events experienced with medical devices should be reported to FDAs MedWatch Adverse Event Reporting program. Reports may be made online, by fax or by mail. For questions, or additional information please contact [email protected].