FDA Device recall Z-0145-2020
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Co…
- FDA Device
- Class II
- terminated
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class II recall of Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Co… by Icu Medical, citing potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0145-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-29 |
| Published | 2019-10-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
Reason
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Identifiers
| code_info | Product Code: 240070401, Lot number (UDI Number): 896485H (20887787009228, 10887787009221), 915625H (20887787009228, 10…Product Code: 240070401, Lot number (UDI Number): 896485H (20887787009228, 10887787009221), 915625H (20887787009228, 10887787009221), 3850054 (20887787009228, 10887787009221) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0145-2020%22
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