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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74437

15 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 14, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
WalkMed Infusion, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

15 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 15

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.

Z-2221-2016
Recall number
Z-2221-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
37 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-204840. Lot Number: 1504031D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 2 of 15

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.

Z-2222-2016
Recall number
Z-2222-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
2453 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300188. Lot Number: 1407012, 1407013, 1407504, 1408125, 1410069D, 1410070D, 1410071D, 1411106D, 1412002D, 1412113D, 1503120D, 1506053D, 1507011D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 3 of 15

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.

Z-2223-2016
Recall number
Z-2223-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
2757 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300197. Lot Number: 1406082, 1407122, 1408126, 1408128, 1410078D, 1410079D, 1410080D, 1410081D, 1410082D, 1411025D, 1411026D, 1501022D, 1501109D, 1503083D, 1507012D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 4 of 15

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.

Z-2224-2016
Recall number
Z-2224-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
3342 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300198. Lot Number: 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, 1506064D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 5 of 15

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.

Z-2225-2016
Recall number
Z-2225-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
7529 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300204. Lot Number: 1406006, 1406008, 1406170, 1406171, 1406172, 1406173, 1406174, 1407125, 1407126, 1407127, 1407128, 1407129, 1408076, 1408077, 1409038D, 1409039D, 1409040D, 1410074D, 1410075D, 1410076D, 1410077D, 1411066D, 1411067D, 1412003D, 1412004D, 1412006D, 1412007D, 1501054D, 1501055D, 1501056D, 1501057D, 1501058D, 1502023D, 1502025D, 1502033D, 1503051D, 1503053D, 1506055D, 1506057D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 6 of 15

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.

Z-2226-2016
Recall number
Z-2226-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
679 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300206. Lot Number: 1406087, 1407505, 1409132D, 1409133D, 1412060D, 1503090D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 7 of 15

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.

Z-2227-2016
Recall number
Z-2227-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
304 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300576. Lot Number: 1407016, 1410164D, 1411070D, 1501024D, 1503091D, 1506091D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 8 of 15

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.

Z-2228-2016
Recall number
Z-2228-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
58 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300577. Lot Number: 1407025

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 9 of 15

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.

Z-2229-2016
Recall number
Z-2229-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
1323 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300642. Lot Number: 1406088, 1406163, 1406164, 1406165, 1409041D, 1409134D, 1410165D, 1506065D, 1508008D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 10 of 15

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.

Z-2230-2016
Recall number
Z-2230-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
1857 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300643. Lot Number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 11 of 15

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.

Z-2231-2016
Recall number
Z-2231-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
2198 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300644. Lot Number: 1406019, 1406020, 1407020, 1407021, 1407022, 1407120, 1407121, 1408133, 1501111D, 1506067D, 1507020D, 1507060D, 1508073D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 12 of 15

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.

Z-2232-2016
Recall number
Z-2232-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
383 total cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300649. Lot Number: 1412061D, 1503069D, 1505046D, 1506087D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 13 of 15

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.

Z-2233-2016
Recall number
Z-2233-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
295 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300650. Lot Number: 1412070D, 1502055D, 1503039D, 1505047D, 1506051D, 1506052D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 14 of 15

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.

Z-2234-2016
Recall number
Z-2234-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
270 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300692. Lot Number: 1407023, 1409042D, 1410166D, 1411072D, 1412062D

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.

device · product 15 of 15

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.

Z-2235-2016
Recall number
Z-2235-2016
Initiated
June 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
WalkMed Infusion, LLC
Quantity
1147 cases

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Product Number: 020-300828. Lot Number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134

Distribution pattern

US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.