CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report

T100-022F with 22 micron filter and FP Clip recalled by WalkMed Infusion

WalkMed Infusion is recalling T100-022F with 22 micron filter and FP Clip, 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

Lot, batch or date codesProduct Number: 020-300649. Lot Number: 1412061D, 1503069D, 1505046D, 1506087D

Quantity recalled383 total cases

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-2232-2016
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

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.

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 Alabama Arizona California Florida Illinois Massachusetts Mississippi New Jersey Nevada New York Ohio Pennsylvania Tennessee Utah Washington

Questions about this recall

Is T100-022F with 22 micron filter and FP Clip recalled?

Yes. WalkMed Infusion recalled T100-022F with 22 micron filter and FP Clip on 14 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2232-2016.

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

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from WalkMed Infusion

All 19

Reported	Class	Recall	Company	Reason	Where
27 Jul 2016Device	CLASS II	T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site recalled	WalkMed Infusion	Particulate Matter	Nationwide
27 Jul 2016Device	CLASS II	T095-022, IV Set with 22 Micron Filter recalled by WalkMed Infusion	WalkMed Infusion	Particulate Matter	Nationwide
27 Jul 2016Device	CLASS II	T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 22 Fltr recalled	WalkMed Infusion	Particulate Matter	Nationwide
27 Jul 2016Device	CLASS II	T100-000F, 100" IV Set with Free Flow Clip recalled by WalkMed Infusion	WalkMed Infusion	Particulate Matter	Nationwide
27 Jul 2016Device	CLASS II	Spike Set, 12" Microbore SPM recalled by WalkMed Infusion	WalkMed Infusion	Particulate Matter	Nationwide

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