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

FDA Device Recall #Z-2354-2019 — Class II — June 10, 2019

Recall Summary

Recall Number Z-2354-2019
Classification Class II — Moderate risk
Date Initiated June 10, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Molded Products Inc
Location Harlan, IA
Product Type Devices
Quantity 130,000 sets

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.

Distribution Pattern

Distribution US nationwide.

Lot / Code Information

LOT NUMBER: 20266 UDI # +B144MPC1251/$$52232420266N Expiration Date 11/20/2022

Other Recalls from Molded Products Inc

Recall # Classification Product Date
Z-1679-2017 Class II Non-Sterile Double DIN to DIN "Y" Connector, ... Jan 20, 2015
Z-0969-2013 Class II Sterile Access & Return Line Set, 36" Length, P... Jun 19, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.