FDA Device recall Z-2617-2021
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Xcela PICC with PASV Valve Technology/Kit 5 F-55cm by Angiodynamics Navilyst Medical, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2617-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-17 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | n/a |
Product
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
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).
Identifiers
| code_info | Lot Number: 5210162 (UDI): H96560M7019951 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All Angiodynamics Navilyst Medical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2617-2021%22
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