Cordis Corporation Recall 88348
Description: Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Cordis Corporation Recall 88348 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2235-2021 |
| Event ID | 88348 |
| Event Description | Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland. |
| Quantity | 8 units |
| Recall 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. |
| Device Classification | 20210818 |
| Device Code Info | Lot/Batch number 82219442 |
| Center Classification Date | 20210809 |
| Recall Initiation Date | 20210719 |
| Recalling Firm | Cordis Corporation |
| Initial Notification | Letter |
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