Z-1157-2014Class II

Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction...

Name: Z-1157-2014 Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction...
Creator: Smith & Nephew Inc.
Published: 2014-01-09
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2014-01-09 / Terminated / root cause: packaging

FDA source

Smith & Nephew Inc. began a recall of Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) on 2014-01-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1157-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-09
Posted: 2014-03-10
Terminated: 2014-09-26
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
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
Root cause tag: packaging
FDA 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 in commerce: 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 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.
Product codes and lots: ALL LOT #s 2013010311 and lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1157-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1157-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10
Z-1158-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10
Z-1159-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10
Z-1160-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10
Z-1161-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10
Z-1162-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10

Product code OMP

K110647Class IIRenasys Foam Npwt Wound Dressing Kits with Suction Pad; Renasys Gauze Npwt Wound Dressing Kits with Suction Pad; RenasysSmith & Nephew, Inc. / cleared 2011-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)