Recall of Curity Saline Dressings Due to Compromised Sterility
Covidien LLC is recalling Curity Saline Dressings because the sterile barrier was breached, compromising sterility. The recall covers 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, and the breach of the sterile barrier for a wound care product presents a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Curity Saline Dressing 8' x 4 (20.3cm x 10.2 cm), Sterile, manufactured by Covidien LLC. The recall is due to a breach of the sterile barrier, which compromises the sterility of the product. The affected product is a sodium chloride dressing saturated in a 20% hypertonic saline solution, designed to promote biological cleansing and aid in the autolytic debridement process.
The recall includes 1,222,080 units of the dressing. Affected lots have numbers beginning with 14, 15, or 16, with the specific exclusion of lots 16J098062, 16J098162, and 16J098262. The expiration dates for the affected units range from February 2017 through November 2019.
The product was distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Australia, Japan, and the United Kingdom. Consumers and healthcare providers should stop using the affected dressings and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 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
- Affected units
- 1,222,080
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 (2)
- Lot Number beginning with: 14
- 15
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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