Recall Z-2354-2019— Molded Products Inc

Name: FDA recall Z-2354-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-10

Class II · Terminated

Class II FDA medical device recall by Molded Products Inc, initiated 2019-06-10, terminated 2021-05-28. It names one FDA 510(k) clearance: K925927. Product: Luer Lock Set - Catalog # MPC-125, for IV administration sets.. Reason: 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..

Recalling firm: Molded Products Inc
Classification: Class II
Status: Terminated
Initiated: 2019-06-10
Terminated: 2021-05-28
Firm location: Harlan, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K925927 — MPC-1000 INJECTION CAP/PLUGMolded Products, Inc.·cleared 1993-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.