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 breach of the barrier.
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, which corresponds to a Severe severity score under the rubric for medical devices with potential for temporary or medically reversible health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (Item Number: 6556), 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 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. The recall covers 87,680 units, specifically all lots beginning with 100000055262 through lot 15B223462X.
Healthcare facilities and consumers should stop using these sponges and contact the manufacturer or the FDA for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
- Manufacturer
- Covidien LLC
- Affected units
- 87,680
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 100000055262 through lot 15B223462X
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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