Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
This recall has been terminated (originally issued July 19, 2021).
- Company
- Cordis Corporation
- Recall Initiated
- July 19, 2021
- Terminated
- February 16, 2023
- Recall Number
- Z-2235-2021
- Quantity
- 8 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Lot / Code Info
Lot/Batch number 82219442
Root Cause
Under Investigation by firm
Action Taken
The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices.
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