FDA Device recall Z-0126-2020
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.…
- 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 High-Pressure Filter PRIMARY I.… 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-0126-2020 |
| 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 High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 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: 118790412, Lot number (UDI Number): 855505H (20887787009020, 10887787009023), 865135H (20887787009020, 10…Product Code: 118790412, Lot number (UDI Number): 855505H (20887787009020, 10887787009023), 865135H (20887787009020, 10887787009023), 918695H (20887787009020, 10887787009023), 928085H (20887787009020, 10887787009023), 937325H (20887787009020, 10887787009023), 3864774 (20887787009020, 10887787009023), 3935434 (20887787009020, 10887787009023), 4011065 (20887787009020, 10887787009023), 4088425 (20887787009020, 10887787009023) |
|---|
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-0126-2020%22
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