Recall Z-0127-2020— ICU Medical Inc

Name: FDA recall Z-0127-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-29

Class II · Terminated

Class II FDA medical device recall by ICU Medical Inc, initiated 2019-07-29, terminated 2024-01-12. It names one FDA 510(k) clearance: K141789. Product: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case. Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets..

Recalling firm: ICU Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2019-07-29
Terminated: 2024-01-12
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADEHospira, Inc.·cleared 2015-01-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Data sourced from openFDA. This site is unofficial and independent of the FDA.