Smith & Nephew RENASYS-F Foam Dressing Kit Recall for Sealing Issues
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.
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 is classified as FDA Class II, and the hazard involves a medical device failure (inadequate sealing and alarm failure) that poses a risk of harm to patients, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew Inc. is recalling the RENASYS-F Foam Dressing Kit with Soft Port, reference numbers 66800794, 66800795, and 66800796. These kits are used in conjunction with negative pressure wound therapy pumps. The recall covers approximately 1,710,773 individual units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
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. This issue is 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 lots are identified as 2013011828 and lower for Small sizes, 2013010125 and lower for Medium sizes, and 2013011692 and lower for Large sizes. Consumers and healthcare providers should stop using these products and contact Smith & Nephew for further instructions.
The recalled product
- Product
- Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (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
- 1,710,773
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 (3)
- ALL LOT #'s: 2013011828 and lower- Small
- 2013010125 and lower- Medium
- and 2013011692 and lower - Large
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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