Reported Mar 19, 2014 · Terminated
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits…
Smith & Nephew Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew Inc. · 970 Lake Carillon Dr · Saint Petersburg, FL · 33716-1130
Is this the product you have?
- 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)
- Lot codes and dates
- ALL LOT #'s 2013010287 and lower
- Amount recalled
- 28,250 individual units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has 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 wo
This product could cause temporary or reversible health problems — stop using it.
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