FDA (Devices) recall action 67477
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Smith & Nephew is recalling RENASYS-F XL with Soft Port dressing kits due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.
Smith & Nephew is recalling RENASYS-F Foam Dressing Kits with Soft Port due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.
Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump alarms.
Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.
Smith & Nephew is recalling RENASYS Gauze with Soft Port Kits because inadequate sealing can cause fluid to remain under the dressing and prevent the pump alarm from activating.
Smith & Nephew is recalling RENASYS Soft Port Dressing Kits because inadequate sealing may prevent wound fluid evacuation and fail to trigger pump alarms.