Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.
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 hazard involves compromised sterility in a surgical product, which poses a significant risk of infection and potential hospitalization.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm), Item Number 6522, manufactured by Covidien LLC. The recall is being conducted because the sterility of the sponges was compromised due to a breach of the barrier packaging.
The affected units include all lots beginning with 110000161662 through lot 15G255462X. A total of 3,152,197 units were distributed nationwide in the United States and in the following countries: 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 distributors should stop using the affected sponges and contact the manufacturer for instructions on how to return or dispose of the product. Patients who have received these sponges during a surgical procedure should contact their healthcare provider for further guidance.
The recalled product
- Product
- Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
- Manufacturer
- Covidien LLC
- Affected units
- 3,152,197
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 110000161662 through lot 15G255462X
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.
See all 13 products in this recall →Related recalls
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