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Covidien LP Recall: Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectab

Covidien LP Recall: Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectab is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Covidien LP; Product: Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectab

Recalling firmCovidien LP
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 unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
Reason for recallMedtronic 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionU.S., Gov Accts, and foreign countries: PA, PR, CO.
Recall initiated20170717
Recall numberZ-0534-2018
Categorydevice
StateGA
CountryUnited States

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