FDA-Device2025-05-28Class I
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Centerline Biomedical Inc
Hazard
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Sold states
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Affected count
80 units
Manufactured in
10000 Cedar Ave, N/A, Cleveland, OH, United States
Products
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1760-2025Don't want to check this manually?
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