Smith & Nephew Recalls Renasys Sterile Transparent Film Due to Seal Failures
Smith & Nephew is recalling Renasys Sterile Transparent Film and related dressing kits because sterility seal integrity failures may compromise the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a sterility failure, which poses a risk of infection (harm) to patients, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling the RENASYS Sterile Transparent Film and all RENASYS Dressing kits that contain this film. The recall is due to sterility seal integrity failures, which may compromise the sterile barrier of the devices.
The affected products are intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates, and infectious materials. Appropriate wound types include chronic, acute, traumatic, sub-acute, and dehisced wounds, ulcers, partial thickness burns, flaps, and grafts.
Approximately 45,455 devices were distributed in the United States, with additional distribution to various international markets. Consumers and healthcare providers should stop using the affected products and contact Smith & Nephew for further instructions.
The recalled product
- Product
- RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and…
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 45,455
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code 66020933 RENASYS G Small with Soft Port - Lots #'s 2015100134
- 2015100313
- 2015100314
- 2016040686
- 2015100315
- 2015100316
- 2015110540
- 2016040715
- 2015100317
- 2015110542
- 2014011449
- 2014030463
- 2014040241
- 2014050736
- 2014051132
- 2014061169
- 2014113986
- 2015020655
- 2015040522
- 2015050927
Distribution
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