Sterile Saline Dressing Recalled Due to Compromised Sterility Barrier
FDA is recalling Kerlix Super Sponge Saline Dressings because the sterile barrier is breached, potentially compromising sterility.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk of harm (infection) from a compromised sterile barrier, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Kerlix Super Sponge Saline Dressing, Sterile, manufactured by Covidien LLC. The recall involves Item Code 3338, a sterile dressing saturated in a 20% hypertonic saline solution designed to promote biological cleansing and autolytic debridement in wounds.
The recall is being conducted because the product's sterility is compromised due to a breach of the sterile barrier. This defect poses a risk of infection to patients using the dressing. The affected units are identified by lot numbers beginning with 14, 15, or 16, with expiration dates ranging from February 2017 through November 2019.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Australia, Japan, and the United Kingdom. A total of 38,794 units are subject to this recall. Users should stop using the affected dressings and contact their supplier or the manufacturer for further instructions.
The recalled product
- Product
- Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Wound Care
- Affected units
- 38,794
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 (3)
- Lot Number beginning with: 14
- 15
- 16 Expiration Date: From February 2017 through November 2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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