The Recall Desk
HighFDA (Devices)·Z-1160-2014·Announced 2014-03-19

Smith & Nephew Recalls RENASYS Gauze with Soft Port Kits

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.

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 functional failure (inadequate sealing and alarm failure) poses a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew Inc. is recalling approximately 498,980 units of RENASYS Gauze with Soft Port Kits. The affected reference numbers are 66800933, 66800934, 66800935, and 66800936. These kits are used in conjunction with negative pressure wound therapy pumps.

The recall is due to reports that wound fluid and/or blood were not evacuated from beneath the wound dressing, and the pump blockage alarm did not 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 2013020417 and lower (Small), 2013020209 and lower (Medium), 2013020382 and lower (Large), and 2013020501 and lower (X-Large). The products were distributed nationwide in the United States, including Puerto Rico, as well as in numerous international locations. Consumers and healthcare providers should stop using the affected kits and contact Smith & Nephew for further instructions.

The recalled product

Product
Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (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
498,980

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 (4)

  • ALL LOT #'s: 2013020417 and lower - Small
  • 2013020209 and lower- Medium
  • 2013020382 and lower - Large
  • and 2013020501 and lower- X-Large

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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