FDA Device recall Z-0138-2020
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filt…
- 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 Primary PLUM Set 15 Micron Filt… 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-0138-2020 |
| 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 Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.
Reason
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Identifiers
| code_info | Product Code: 140099291, Lot number (UDI Number): 3981726 (10887709100166, 20887709100163), 4065006 (10887709100166, 20887709100163) |
|---|
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-0138-2020%22
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