Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves compromised sterility in a medical device, which poses a risk of infection or harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm), Item Number 4031. The recall was initiated by the manufacturer, Covidien LLC, because the product's sterility was compromised due to a breach of the barrier packaging.
The affected units 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. The recall covers all lots beginning with 110000311162 through lot 15J101262X. A total of 208,348 units are subject to this recall.
Healthcare facilities and consumers should stop using the affected sponges immediately. Users should contact the manufacturer, Covidien LLC, for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
- Manufacturer
- Covidien LLC
- Affected units
- 208,348
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 110000311162 through lot 15J101262X
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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