Z-2354-2019Class II

Luer Lock Set - Catalog # MPC-125, for IV administration sets

Name: Z-2354-2019 Luer Lock Set - Catalog # MPC-125, for IV administration sets
Creator: Molded Products Inc
Published: 2019-06-10
License: https://open.fda.gov/license/

Molded Products Inc / initiated 2019-06-10 / Terminated / root cause: packaging

FDA source

Molded Products Inc began a recall of Luer Lock Set - Catalog # MPC-125, for IV administration sets on 2019-06-10. FDA classified it as Class II and gives the reason as "Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2354-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-10
Posted: 2019-08-22
Terminated: 2021-05-28
Recalling firm: Molded Products Inc
Product: Luer Lock Set - Catalog # MPC-125, for IV administration sets.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On June 10, 2019, the firm sent URGENT MEDICAL DEVICE RECALL letters to their consignees advising them of the labeling problem, requesting that they check their stock, notify their end users and complete the attached MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM.
Quantity in commerce: 130,000 sets
Distribution: Distribution US nationwide.
Product codes and lots: LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2354-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2354-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code FPA

K925927Class IIMpc-1000 Injection Cap/plugMolded Products, Inc. / cleared 1993-08-16

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)