FDAFDA · Food and drugs·Recall number Z-0534-2018
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 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.
Published February 14, 2018 · Recall initiated: July 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LP
- Distributor
- U.S., Gov Accts, and foreign countries: PA, PR, CO.
- Lot
- Lot Numbers: 17E121362, 17E121262 UDI: 10884527016990; 20884527016997
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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