Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from 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 or serious injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (Item Number: 4037), manufactured by Covidien LLC. The recall is due to compromised sterility resulting from a breach of the product's barrier.
The affected units were 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 covers approximately 28,085 units, including all lots beginning with 110000311262 through lot 15G162262X.
Healthcare facilities and consumers should stop using these sponges and contact the manufacturer or their supplier for instructions on return or replacement. Using non-sterile surgical sponges can pose a risk of infection to patients.
The recalled product
- Product
- Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
- Manufacturer
- Covidien LLC
- Affected units
- 28,085
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 110000311262 through lot 15G162262X
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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