Device product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Z-2235-2021
Product summary
- Event
- Event 88348
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-2235-2021
Official wording
Reason: The 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.
Code information: Lot/Batch number 82219442
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Derived failure modes
-
Foreign material or chemical contamination
foreign material