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.
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. According to the rubric, an FDA Class II recall involving a compromised sterile barrier for a surgical device is categorized as Severe (Score 4) due to the potential for significant injury from infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm), Item Number 6534. The recall was initiated by the manufacturer, Covidien LLC, due to a breach of the barrier packaging that may have compromised the sterility of the medical devices.
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 all lots beginning with 110000476162 through lot 15J070162X. The total quantity of affected units is 350,550.
Healthcare facilities and consumers should stop using these sponges immediately. Users should check their inventory for the specific item number and lot numbers listed in this notice. If the product is found, it should be quarantined and returned to the manufacturer or the distributor from whom it was purchased, in accordance with the recall instructions provided by Covidien LLC.
The recalled product
- Product
- Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
- Manufacturer
- Covidien LLC
- Affected units
- 350,550
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 110000476162 through lot 15J070162X
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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