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.
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 of a surgical device, which poses a significant risk of infection or injury to patients.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm), Item Number 6545, manufactured by Covidien LLC. The recall involves 70,960 units of the product.
The reason for the recall is compromised sterility due to a breach of the barrier packaging. This defect could potentially allow contamination of the sponges, which are intended for use in surgical procedures.
The affected lots range from 110001420362 through 15C151862X. The products were 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. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected sponges.
The recalled product
- Product
- Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545
- Manufacturer
- Covidien LLC
- Affected units
- 70,960
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 110001420362 through lot 15C151862X
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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