Agency classClass IIOur severity:High FDA (Devices)·Z-1742-2017·Announced 2017-04-12

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.

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 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…
Manufacturer: Covidien LLC
Category: Medical Device — Wound Care
Hazard: sterility-compromise
infection-risk
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.

See all 7 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise