FDA Device recall Z-0629-2024
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
- FDA Device
- Class II
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class II recall of Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY by Merit Medical Systems, citing the sterility of microcatheter and infusion system devices cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0629-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-06 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Reason
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Identifiers
| code_info | REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0629-2024%22
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