Z-2230-2016Class II

T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case

Name: Z-2230-2016 T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case
Creator: WalkMed Infusion, LLC
Published: 2016-06-14
License: https://open.fda.gov/license/

WalkMed Technologies, LLC / initiated 2016-06-14 / Terminated / root cause: manufacturing process

FDA source

WalkMed Infusion, LLC began a recall of 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... on 2016-06-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2230-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-14
Posted: 2016-07-18
Terminated: 2016-12-01
Recalling firm: WalkMed Technologies, LLC
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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Terumo sent a notification letter dated June 8, 2016 to customers. The letter identified the affected product, problem and action to be taken. Customers were instructed to 1. Review this notice and ensure that all users receive notice of this issue. 2. Return the attached Customer Response Form acknowledging receipt of this notice. 3. Source a replacement for the Interchlor sanitizer. See information above or call Terumo CVS Technical Support for assistance. 4. Terumo CVS will provide users with updated user instructions regarding the 10% Sodium Hypochlorite sanitization solution. Instructions will be provided under separate cover, when available. For questions contact your Terumo representative or contact Terumo CVS Technical Support at 800.441.3220, extension 6932.
Quantity in commerce: 1857 cases
Distribution: US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
Product codes and lots: Product Number: 020-300643. Lot Number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2230-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2221-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2222-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2223-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2224-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2225-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2226-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2227-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2228-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2229-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2230-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2231-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2232-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2233-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2234-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18
Z-2235-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-18

Product code FPA

K073444Class IITriton Meidcal Tmed IV-SetTriton Medical, LLC / cleared 2008-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)