Curity All Purpose Sponges Recalled Due to Compromised Sterility
FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.
What this means for you
Illness, injury, or structural failure has been reported. 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 rating under the rubric, particularly given the risk of infection from compromised sterility in a medical device.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm), Item Number 8047, manufactured by Covidien LLC. The recall is due to compromised sterility resulting from a breach of the product's barrier.
The affected lots range from 110000233562 through 120002651262X. A total of 2,418,560 units were distributed nationwide in the United States and in the countries of 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.
Healthcare facilities and consumers should stop using the affected sponges immediately. Users should contact their supplier or the manufacturer for instructions on how to return or dispose of the product.
The recalled product
- Product
- Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
- Manufacturer
- Covidien LLC
- Affected units
- 2,418,560
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 110000233562 through lot 120002651262X
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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