GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, p...
FDA Device Recall #Z-0940-2013 — Class I — February 25, 2013
Recall Summary
| Recall Number | Z-0940-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | February 25, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Symbios Medical Products, LLC |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 458 |
Product Description
GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management
Reason for Recall
Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
Distribution Pattern
Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
Lot / Code Information
Kit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125 Kit Part Number 510112-BP, lot 12-101110, 12-101103 Kit: 510401-BP lot 12-101045 Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit All Kits contain Pump Part Number: 510076 Lot Number: 12-100601
Other Recalls from Symbios Medical Products, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1457-2013 | Class I | Part 510449 Disposable Infusion Pump, ...Elast... | May 10, 2013 |
| Z-1462-2013 | Class I | Part 510636 Disposable Infusion Pump, ...Elast... | May 10, 2013 |
| Z-1454-2013 | Class I | Part 510180 Disposable Single Infusion Pump, ..... | May 10, 2013 |
| Z-1459-2013 | Class I | Part 510490 Disposable Infusion Pump, ...Elast... | May 10, 2013 |
| Z-1456-2013 | Class I | Part510447 Disposable Infusion Pump, ...Elasto... | May 10, 2013 |
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.