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)
- Company
- Smith & Nephew Inc.
- Recall Initiated
- January 9, 2014
- Posted
- March 10, 2014
- Terminated
- September 26, 2014
- Recall Number
- Z-1161-2014
- Quantity
- 7,353 individuals units
- Firm Location
- Saint Petersburg, FL
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
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 / Code Info
ALL LOT #s 2013020740 and lower
Root Cause
Packaging change control
Action Taken
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.