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Cordis Corporation Recall 88348

Description: Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Cordis Corporation Recall 88348 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2235-2021
Event ID88348
Event DescriptionCordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Quantity8 units
Recall ReasonThe balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Device Classification20210818
Device Code InfoLot/Batch number 82219442
Center Classification Date20210809
Recall Initiation Date20210719
Recalling FirmCordis Corporation
Initial Notification Letter
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