FDA (Devices) recall action 77560

ICU Medical, Inc. recalled 9 products on 2017-07-19

The FDA (Devices) publishes a recall like this one as 9 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 9 pages.

Products: 9
Announced: 2017-07-19
Critical: 0
Units: 2,750

Why these products were recalled

The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.

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

1–9 of 9

HighFDA (Devices)··2017-07-19
ICU Medical Recalls Smallbore Extension Sets Due to Potential Leak
ICU Medical is recalling 120 units of smallbore extension sets because the connection between the Female Luer and NanoClave manifold may develop a leak.
Product
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 1,100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
Product
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls 28 cm Bifuse Extension Sets Due to Leak Risk
ICU Medical is recalling 50 units of 28 cm Bifuse Extension Sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
Product
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls 28 cm Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 6 units of 28 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.
Product
28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls Proximale Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 70 units of Proximale Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.
Product
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 900 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
Product
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.
Product
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk
ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may leak.
Product
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
Category
Distribution
4 states
HighFDA (Devices)··2017-07-19
ICU Medical Recalls MicroClave Extension Sets Due to Leak Risk
ICU Medical is recalling 100 units of MicroClave extension set kits because the connection between the Female Luer and the NanoClave manifold may develop a leak.
Product
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter…
Category
Distribution
4 states