CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report
T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site recalled
WalkMed Infusion is recalling T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site, distributed nationwide in the US. The recall was initiated on 14 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2224-2016
- FDA event ID
- 74437
- Recalling firm
- WalkMed Infusion, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jun 2016
- FDA classified
- 18 Jul 2016
- Reported
- 27 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 14 Jun 2016 | Recall initiated by company | |
| 18 Jul 2016 | Classified by FDA | +34 days |
| 27 Jul 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
Nationwide AlabamaArizonaCaliforniaFloridaIllinoisMassachusettsMississippiNew JerseyNevadaNew YorkOhioPennsylvaniaTennesseeUtahWashington
Questions about this recall
Why was it 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.
Which lots are affected?
Product Number: 020-300198. Lot Number: 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, 1506064D
Where was it sold?
US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 74437This product is part of a recall event; the main page for the event is T095-120 IV Set with 1.2 Micron Filter recalled by WalkMed Infusion.
More recalls from WalkMed Infusion
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | T095-022, IV Set with 0.22 Micron Filter recalled by WalkMed Infusion | WalkMed Infusion | Particulate Matter | Nationwide |
| Device | CLASS II | T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr recalled | WalkMed Infusion | Particulate Matter | Nationwide |
| Device | CLASS II | T100-000F, 100" IV Set with Free Flow Clip recalled by WalkMed Infusion | WalkMed Infusion | Particulate Matter | Nationwide |
| Device | CLASS II | Spike Set, 12" Microbore SPM recalled by WalkMed Infusion | WalkMed Infusion | Particulate Matter | Nationwide |
| Device | CLASS II | T030-000 -30" 20 Drop IV Admin Secondary Set recalled | WalkMed Infusion | Particulate Matter | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |