FDA (Devices) recall action 80288

Cardinal Health 200, LLC recalled 11 products on 2018-07-25

The FDA (Devices) publishes a recall like this one as 11 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 11 pages.

Products: 11
Announced: 2018-07-25
Critical: 0
Units: 693,220

Why these products were recalled

The suction valve may not close properly which could cause continuous suction.

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

1–11 of 11

HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. .
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states
HighFDA (Devices)··2018-07-25
Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect
Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.
Product
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Category
Distribution
34 states