Curity Gauze Sponges Recalled for Compromised Sterility
Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.
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, which corresponds to a 'Severe' severity score under the rubric, particularly given the risk of infection from non-sterile medical devices used in surgical incisions.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch, Item Number 397310. The recall was initiated by the manufacturer, Covidien LLC, due to compromised sterility resulting from a breach of the barrier packaging.
The affected products are open mesh fabric sponges intended to be used inside the body or in surgical incisions to control bleeding, absorb fluid, or protect organs. The recall covers 713,600 units distributed nationwide in the United States and in Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, and the United Kingdom.
The recall includes all lots beginning with 110000037462 through Lot 120002259962. Healthcare facilities and consumers should stop using these products and contact the manufacturer or the FDA for further instructions on how to return or dispose of the affected sponges.
The recalled product
- Product
- Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Gauze
- Affected units
- 713,600
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 (1)
- All lots beginning with 110000037462 through Lot 120002259962
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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