The Recall Desk
HighFDA (Devices)·Z-1161-2014·Announced 2014-03-19

Smith & Nephew RENASYS-G Gauze Dressing Kit Recall for Sealing Issues

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.

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 where a defect (inadequate sealing) leads to a failure of a critical safety function (fluid evacuation and alarm activation), creating a risk of harm, but the source text does not explicitly report injuries or fatalities.

Plain-English summary

Smith & Nephew Inc. is recalling 7,353 units of RENASYS-G Sterile, Gauze Dressing Kits with Soft Port (REF #66800961). These kits are used in conjunction with negative pressure wound therapy pumps. The recall covers all lot numbers 2013020740 and lower.

The recall is being issued because of reports that wound fluid and/or blood were not evacuated from beneath the wound dressing, and the pump blockage alarm did not activate. These issues have 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 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 kits and contact Smith & Nephew for instructions on return or replacement.

The recalled product

Product
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (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
Hazard
Affected units
7,353

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 #s 2013020740 and lower

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Smith & Nephew Inc.

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Same hazard · fluid evacuation failure

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