Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 20...
FDA Device Recall #Z-2261-2016 — Class II — June 23, 2016
Recall Summary
| Recall Number | Z-2261-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 23, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | The Metrix Company |
| Location | Dubuque, IA |
| Product Type | Devices |
| Quantity | 18,366 cases |
Product Description
Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Reason for Recall
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Distribution Pattern
Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
Lot / Code Information
All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58740, 58741, 58742, 58749, 58750, 58753, 58754
Other Recalls from The Metrix Company
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0344-2025 | Class II | Imed Products Imed EVA BAG, 500 mL, 2-PORTS, RE... | Oct 9, 2024 |
| Z-0342-2025 | Class II | Imed Products Imed EVA BAG, 150 mL, 2-PORTS, RE... | Oct 9, 2024 |
| Z-0339-2025 | Class II | SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports,... | Oct 9, 2024 |
| Z-0330-2025 | Class II | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, ... | Oct 9, 2024 |
| Z-0335-2025 | Class II | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports,... | Oct 9, 2024 |
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.