Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch,...
FDA Device Recall #Z-2195-2014 — Class II — July 18, 2014
Recall Summary
| Recall Number | Z-2195-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 18, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Gambro Renal Products, Incorporated |
| Location | Lakewood, CO |
| Product Type | Devices |
| Quantity | 401,451 |
Product Description
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Reason for Recall
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Distribution Pattern
Worldwide Distribution.
Lot / Code Information
Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.
Other Recalls from Gambro Renal Products, Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2197-2014 | Class II | Prisma M 100 PRE set. Product number 103657. Ea... | Jul 18, 2014 |
| Z-2204-2014 | Class II | Prismaflex HF 1000. Product number 107140. Each... | Jul 18, 2014 |
| Z-2194-2014 | Class II | Prisma TPE 2000 set. Product number 109672. Eac... | Jul 18, 2014 |
| Z-2203-2014 | Class II | Prismaflex M150. Product number 109990. Each se... | Jul 18, 2014 |
| Z-2207-2014 | Class II | X-MARS Set (component of MARS Treatment Kit Typ... | Jul 18, 2014 |
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.