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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Recall Number Z-1157-2014
Classification Class II
Code Info ALL LOT #s 2013010311 and lower
Product Distributed Qty 162,629 invididual units
Reason For Recall 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 wound contact dressing and may adversely affect the performance of the blockage alarm.

Event Detail

Event Id 67477
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc.
City Saint Petersburg
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-09
Initial Firm Notification of Consignee or Public
Distribution Pattern Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.