Angiodynamics Inc. (Navilyst Medical Inc.) Recall 88596
Description: Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Angiodynamics Inc. (Navilyst Medical Inc.) Recall 88596 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2617-2021 |
| Event ID | 88596 |
| Event Description | Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995 |
| Product Type | Devices |
| Distribution | Canada |
| Quantity | 4 boxes (5/each)= 20 eaches |
| Recall Reason | Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec). |
| Device Classification | 20211006 |
| Device Code Info | Lot Number: 5210162 (UDI): H96560M7019951 |
| Center Classification Date | 20210930 |
| Recall Initiation Date | 20171017 |
| Recalling Firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Initial Notification | Letter |
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