Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.
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, and the hazard involves compromised sterility of a medical device, which poses a significant risk of infection or serious injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm), Item Number 6022, manufactured by Covidien LLC. The recall is being conducted because a breach of the barrier packaging may have compromised the sterility of the sponges.
The affected product was distributed nationwide in the United States as well as 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 covers all lots beginning with 110000463762 through lot 15K235262.
Healthcare facilities and consumers should stop using the affected sponges and contact the manufacturer or the FDA for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
- Manufacturer
- Covidien LLC
- Affected units
- 996,002
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 110000463762 through lot 15K235262
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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