Recall of Sterile Wound Dressings Due to Compromised Sterility Barrier
Covidien is recalling Curity Wet Dressings because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.
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 compromised sterility in a medical device, which aligns with 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 has issued a Class II recall for Covidien Curity Wet Dressings, Item Code 3337. The recall is due to a breach of the sterile barrier, which compromises the sterility of the product. The affected dressings are saturated in a 20% hypertonic saline solution and are designed to promote biological cleansing and aid in autolytic debridement.
The recall covers 104,688 units of the 8 x 4 inch (20.3 cm x 10.2 cm) sterile dressings. Affected lots have numbers beginning with 14, 15, or 16, with expiration dates ranging from February 2017 through November 2019. The product was distributed nationwide in the United States and internationally to numerous countries, including Canada, Australia, Japan, Mexico, and the United Kingdom.
Healthcare providers and consumers should stop using the affected dressings immediately. Users should contact their supplier or the manufacturer for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 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 debridem
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Wound Care
- Affected units
- 104,688
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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