Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s:… — Class II medical device recall Z-1158-2014
Terminated recall by Smith & Nephew Inc., reported 2014-03-19, distributed nationwide. Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump bloc
| Recall number | Z-1158-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc., Saint Petersburg, FL, United States |
| Recall initiated | 2014-01-09 |
| Classified | 2014-03-10 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2014-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CL, CW, DE, FR, GB, HK, KW, LB, LK, MY, NZ, SA, SG, TR, VN, ZA |
| Quantity | 1,710,773 invididuals |
| Reason classes | packaging |
| Lot numbers | 2013011828 |
| Model numbers | 66800794, 66800795, 66800796 |
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)
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1158-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.