FDA (Devices) recall action 83549

ICU Medical Inc recalled 22 products on 2019-10-23

The FDA (Devices) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.

Products: 22
Announced: 2019-10-23
Critical: 0
Units: 985,597

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–22 of 22

HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 170,735 units distributed nationwide and internationally.
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…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of air vents.
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…
Category
Distribution
53 states
SevereFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
ICU Medical is recalling Sapphire Epidural Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 26,700 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.
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…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 19,350 units distributed nationwide and internationally.
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, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL.…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters because fluid may leak out of the air vents. The recall covers 45,900 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 6,400 units distributed in the U.S. and internationally.
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…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling 521 units of Plum Microbore Infusion Sets because air vents on inline filters may leak fluid. The recall covers nationwide and international distribution.
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, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage
ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.
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…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents. The product was distributed in the U.S. and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 4,600 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.
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…
Category
Distribution
53 states
HighFDA (Devices)··2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
Category
Distribution
53 states
SevereFDA (Devices)··2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with inline filters because they may leak fluid from air vents. The affected units were distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Category
Distribution
53 states