FDA Device recall Z-0140-2020
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron…
- 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 Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron… 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-0140-2020 |
| 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 Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters 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: 163353155, Lot number 885685H, 3959757 |
|---|
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-0140-2020%22
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