Z-2235-2021 Class II Terminated
FDA device recall Z-2235-2021 was initiated by Cordis Corporation on July 19, 2021 and is designated Class II. 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. The recall status is terminated (terminated February 16, 2023). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- July 19, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
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 Pattern
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Code Information
Lot/Batch number 82219442