The Recall Desk
HighFDA (Devices)·Z-1162-2014·Announced 2014-03-19

Smith & Nephew RENASYS-AB Abdominal Dressing Kit Recall for Sealing Defects

Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump 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 safety mechanism (alarm) and inefficient treatment (fluid evacuation). This fits the 'High' criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew Inc. is recalling 28,250 units of the RENASYS-AB Abdominal Dressing Kit with Soft Port (REF #66800980). These kits are used in conjunction with negative pressure wound therapy pumps. The recall covers all lot numbers 2013010287 and lower.

The recall was initiated due to reports of wound fluid and/or blood not being evacuated from beneath the dressing. Additionally, the pump blockage alarm did not activate in these instances. The 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.

The affected products were distributed nationwide in the United States, including Puerto Rico, and internationally to numerous countries including Australia, Germany, France, and Singapore. Consumers and healthcare providers should stop using the affected kits and contact Smith & Nephew for instructions on replacement or return.

The recalled product

Product
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (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
28,250

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 2013010287 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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