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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Class II 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. 28,250 individual units Z-1162-2014
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 Class II 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. 7,353 individuals units Z-1161-2014
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 Class II 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. 498,980 individuals units Z-1160-2014
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 Class II 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. 15,754 indivdual units Z-1159-2014
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 Class II 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. 1,710,773 invididuals units Z-1158-2014
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 Class II 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. 162,629 invididual units Z-1157-2014
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