medical Class II Updated 2019-10-23

ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbo

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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)

View official government recall

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