FDA Device recall Z-1637-2018
PICC Tray, Product Code: AMS-9093CP 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 Tray, Product Code: AMS-9093CP 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-1637-2018 |
| 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 Tray, Product Code: AMS-9093CP 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 Numbers: 16I026D & 16J032D UDI: 08498840004784 |
|---|
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-1637-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.