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U.S. Department of Health and Human Services

Class 2 Device Recall RENASYSF XL with Soft Port

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 Class 2 Device Recall RENASYSF XL with Soft Portsee related information
Date Initiated by FirmJanuary 09, 2014
Date PostedMarch 10, 2014
Recall Status1 Terminated 3 on September 26, 2014
Recall NumberZ-1159-2014
Recall Event ID 67477
510(K)NumberK110647 
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
ProductSmith & 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)
Code Information ALL LOT #: 2013011830 and lower
Recalling Firm/
Manufacturer		 Smith & Nephew Inc.
970 Lake Carillon Dr
Ste 110
Saint Petersburg FL 33716-1130
For Additional Information ContactCustomer Care
800-876-1261
Manufacturer 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 wo
FDA Determined
Cause 2		Packaging change control
ActionA product bulletin titled "Soft Port Enhancements" dated March 14, 2013, was released for external distribution describing the changes to the Soft Port products, e.g. increasing the Soft Port orifices size and adding a second slit to the release paper covering the port adhesive, and stating the purpose of the modifications to the device. These product bulletin was provided to sales representatives for distribution to customers requesting information regarding the design enhancement made to the Soft Port product range. The bulletin was not distributed to all the customers. To ensure that the product modification and its purpose was appropriately communicated to consignees of affected product a Medical Device Correction Notice, dated 01/22/2014, retrospectively advising customers of the modification to the Soft Port products has been prepared and was sent to consignees of the affected products on the same date.
Quantity in Commerce15,754 indivdual units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OMP
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