Recall Z-1160-2014 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew Inc.
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)
| Date | Mar 10, 2014 (initiated Jan 9, 2014) |
| Status | Terminated |
| 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 |
| Quantity | 498,980 individuals 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110647 | RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS Smith & Nephew, Inc., Jun 22, 2011 |