Reported Feb 14, 2018 · Terminated
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray…
Covidien LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LP · 1430 Marvin Griffin Rd · Augusta, GA · 30906-3851
Is this the product you have?
- Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge
- product UsageVistec 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
- Lot codes and dates
- Lot Numbers
17E12136217E121262
- UDI
1088452701699020884527016997
- Lot Numbers
- Amount recalled
- 33,280
Where it was sold
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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