Recall of Vistec X-Ray Detectable Sponges Due to Sterility Breach
Covidien LLC is recalling Vistec X-Ray Detectable Sponges because a breach of the barrier packaging may have compromised 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from compromised sterility in a medical device.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm), Item Number 7321, manufactured by Covidien LLC. The recall involves 199,488 units of the product.
The recall was initiated because a breach of the barrier packaging may have compromised the sterility of the sponges. This defect poses a risk of infection if the non-sterile sponges are used in a surgical setting.
The affected lots range from 100000009962 through 15J163262X. The products 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. Healthcare facilities should stop using the affected sponges and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
- Manufacturer
- Covidien LLC
- Affected units
- 199,488
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 100000009962 through lot 15J163262X
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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