Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of...
FDA Device Recall #Z-0444-2013 — Class II — September 20, 2011
Recall Summary
| Recall Number | Z-0444-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 20, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Metrex Research, LLC. |
| Location | Romulus, MI |
| Product Type | Devices |
| Quantity | 3,348 units |
Product Description
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
Reason for Recall
The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
Lot / Code Information
Part Number Lot Number 4511 201008270110
Other Recalls from Metrex Research, LLC.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1402-2017 | Class II | CaviWipes1 Extra Large, Part No. 13-5150 The b... | Jan 20, 2017 |
| Z-2267-2012 | Class II | CaviCide, Part Numbers: 13-1025, 13-1000, 13-1... | Feb 6, 2012 |
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.