FDA (Devices) recall action 74437

WalkMed Infusion, LLC recalled 15 products on 2016-07-27

The FDA (Devices) publishes a recall like this one as 15 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 15 pages.

Products: 15
Announced: 2016-07-27
Critical: 0
Units: 24,632

Why these products were recalled

WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration 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

1–15 of 15

HighFDA (Devices)··2016-07-27
WalkMed Infusion Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Infusion Recalls Spike Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling 12-inch Microbore Spike Sets due to the potential presence of particulate matter in or on the devices.
Product
Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Infusion Recalls Triton Administration Sets Due to Particulate Presence
WalkMed Infusion is voluntarily recalling Triton Administration Sets because they may contain particulate matter. The recall affects 383 cases distributed nationwide.
Product
T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter on or in the devices.
Product
T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of T100-000VF IV sets due to the potential presence of particulate matter in or on the devices.
Product
T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
WalkMed Infusion, LLC is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Infusion Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling T100-000F IV sets due to the potential presence of particulate matter in or on the devices.
Product
T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
ModerateFDA (Devices)··2016-07-27
WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Administration Sets Due to Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of IV sets with 0.22 micron filters due to the potential presence of particulate matter in or on the devices.
Product
T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Infusion Recalls Triton Administration Sets Due to Particulate Presence
WalkMed Infusion is voluntarily recalling Triton Administration Sets due to the potential presence of particulate matter in or on the devices.
Product
T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states
HighFDA (Devices)··2016-07-27
WalkMed Recalls IV Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Distribution
15 states