AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition comp...
FDA Device Recall #Z-2141-2012 — Class I — July 13, 2012
Recall Summary
| Recall Number | Z-2141-2012 |
| Classification | Class I — Serious risk |
| Date Initiated | July 13, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corp. |
| Location | Round Lake, IL |
| Product Type | Devices |
| Quantity | 3106 units |
Product Description
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
Reason for Recall
After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
Distribution Pattern
Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom.
Lot / Code Information
Product codes 2M8286 and 2M8286K, all serial numbers
Other Recalls from Baxter Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0370-2017 | Class II | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclea... | Oct 12, 2016 |
| Z-0670-2017 | Class II | sigma spectrum VOLUMETRIC INFUSION PUMP with Ma... | Sep 28, 2016 |
| Z-0671-2017 | Class II | Baxter SIGMA Spectrum INFUSION PUMP with Master... | Sep 28, 2016 |
| Z-0672-2017 | Class II | V6 Rear Case Assembly, Product Code 35701, a re... | Sep 28, 2016 |
| Z-2533-2016 | Class II | Synovis VASCU-GUARD Peripheral Vascular Patch i... | Jun 24, 2016 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
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.