Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negativ
FDA device recall Z-1157-2014 · posted 2014-03-10 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc.
- 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
- 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.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 162,629 invididual 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 a
- Date initiated
- 2014-01-09
- Date posted
- 2014-03-10
- Date terminated
- 2014-09-26
- Location
- Saint Petersburg, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS (K110647) | Smith & Nephew, Inc. | 2011-06-22 |