Agency classClass IIOur severity:Severe FDA (Devices)·Z-1744-2017·Announced 2017-04-12

Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise

Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury (such as infection from non-sterile medical devices) or where the agency classification is Class II are typically scored as Severe (4), especially given the direct application to infected wounds.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Curity Sodium Chloride Dressing, 6 x 6-3/4 inches (15.2 cm x 17.1 cm), sterile, Item Code 3339, manufactured by Covidien LLC. The recall is being conducted because the product's sterility is compromised due to a breach of the sterile barrier. This dressing is indicated for use on exudating and/or infected wounds.

The affected products are identified by lot numbers beginning with 14, 15, or 16 and have expiration dates ranging from February 2017 through November 2019. The recall covers 168,824 units that were distributed worldwide, including the United States (nationwide) and numerous international markets such as Canada, Australia, Japan, Mexico, and various European and Middle Eastern countries.

Consumers and healthcare providers should stop using the affected dressings immediately. Because the sterile barrier is breached, the product may not be sterile, posing a risk of infection when used on wounds. Users should contact their supplier or the manufacturer for instructions on returning or replacing the product.

The recalled product

Product: Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
Manufacturer: Covidien LLC
Category: Medical Device — Wound Care
Hazard: infection
sterility-compromise
Affected units: 168,824

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 →

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