Smith & Nephew Inc.: 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

Agency Publication Date: March 10, 2014

Affected Products

Product: Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)

ALL LOT #s 2013010311 and lower

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)

ALL LOT #'s: 2013011828 and lower- Small, 2013010125 and lower- Medium, and 2013011692 and lower - Large

Product: Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)

ALL LOT #: 2013011830 and lower

Lot Numbers:

2013011830

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)

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

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)

ALL LOT #s 2013020740 and lower

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)

ALL LOT #'s 2013010287 and lower

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67477

Status: Resolved

Manufacturer: Smith & Nephew Inc.

Manufactured In: United States

Units Affected: 6 products (162,629 invididual units; 1,710,773 invididuals units; 15,754 indivdual units; 498,980 individuals units; 7,353 individuals units; 28,250 individual units)

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Sources: FDA iRES · Raw API Response

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