FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc.: 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)
- Recall number
- Z-1158-2014
- Recalling firm
- Smith & Nephew Inc.
- 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)
- Status
- Terminated
- Initiated
- 2014-01-09
- Posted
- 2014-03-10
- Terminated
- 2014-09-26
- Reason
- 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
- Root cause
- Packaging change control
- Action
- A 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
- 1,710,773 invididuals units
- Distribution
- 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.
- Lot, serial or model codes
- ALL LOT #'s: 2013011828 and lower- Small, 2013010125 and lower- Medium, and 2013011692 and lower - Large
- 510(k) numbers
- ["K110647"]
- PMA numbers
- not on file
- Product code
- OMP
- Firm FEI
- 3006760724
- Firm city
- Saint Petersburg
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28