Z-3240-2017Class II

SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R

Name: Z-3240-2017 SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R
Creator: The Metrix Company
Published: 2017-09-13
License: https://open.fda.gov/license/

The Metrix Company / initiated 2017-09-13 / Terminated / root cause: labeling and UDI

FDA source

The Metrix Company began a recall of SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R on 2017-09-13. FDA classified it as Class II and gives the reason as "The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3240-2017
Classification: Class II
Status: Terminated
Initiated: 2017-09-13
Posted: 2017-09-29
Terminated: 2018-05-25
Recalling firm: The Metrix Company
Product: SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Product code: KPE Container, I.V.
Reason for recall: The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Recall letters will be sent to each consignee (distributors) via FedEx. The letter requested the following: "The Metrix Company is asking all customers to follow the steps below: 1. Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Destroy all affected products and dispose/recycle in a manner consistent with your local waste disposal authority. 4. Complete the Response form and return it to The Metrix Company according to the instructions on the form." Distributors were instructed to contact their customers about the recall. The product is to be destroyed in the field.
Quantity in commerce: 50 cases of 200 units
Distribution: AZ, MA, IL, FL
Product codes and lots: UDI: 50812496011850, Lot Numbers: 28990, 29093, 29135, 29244.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3240-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3240-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-11	2017-09-29

Product code KPE

K843523Class IIEmpty Solution Transfer Container 1000Polymer Technology Corp. / cleared 1984-10-16

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)