Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medica...
FDA Device Recall #Z-0969-2013 — Class II — June 19, 2012
Recall Summary
| Recall Number | Z-0969-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 19, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Molded Products Inc |
| Location | Harlan, IA |
| Product Type | Devices |
| Quantity | 1200 sets |
Product Description
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Reason for Recall
The recalled product leaks at the connection site.
Distribution Pattern
Distributed to one customer in Michigan.
Lot / Code Information
Lot numbers: 80106 and 80106b
Other Recalls from Molded Products Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2354-2019 | Class II | Luer Lock Set - Catalog # MPC-125, for IV admin... | Jun 10, 2019 |
| Z-1679-2017 | Class II | Non-Sterile Double DIN to DIN "Y" Connector, ... | Jan 20, 2015 |
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.