Smith & Nephew RENASYS-F XL Dressing Kits Recalled for Sealing Defects
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (inadequate sealing) that leads to inefficient fluid evacuation and alarm failure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Smith & Nephew Inc. is recalling 15,754 individual units of the RENASYS-F XL with Soft Port (REF #: 66800797). These dressing kits are used in conjunction with negative pressure wound therapy pumps. The recall covers all units with lot number 2013011830 and lower.
The recall was initiated due to reports of wound fluid and/or blood not being evacuated from beneath the wound dressing, with the pump blockage alarm failing to activate. These issues are 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 wound.
The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous international locations. Consumers and healthcare providers should stop using the affected products and contact Smith & Nephew for further instructions.
The recalled product
- Product
- Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
- Manufacturer
- Smith & Nephew Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 15,754
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL LOT #: 2013011830 and lower
Distribution
Part of a larger recall action
This product is one of 6 recalled by Smith & Nephew Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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