FDA Device recall Z-1633-2018
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system by Vygon U, citing potential friction holes may affect the sterility of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1633-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-28 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vygon U |
| Distribution | US |
Product
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Reason
Potential friction holes may affect the sterility of the product.
Identifiers
| code_info | Lot Number: 17B012D UDI: 08498840009802 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1633-2018%22
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