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[Recalled] Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductCovidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain uniq
Brand / manufacturerCovidien LP
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0534-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date17 July 2017
EAN / barcode10884527016990

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Covidien LP

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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