Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9...
FDA Device Recall #Z-0145-2015 — Class II — August 6, 2014
Recall Summary
| Recall Number | Z-0145-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 6, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Parker Laboratories, Inc. |
| Location | Fairfield, NJ |
| Product Type | Devices |
| Quantity | 367 boxes |
Product Description
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
Reason for Recall
Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and country of: Canada.
Lot / Code Information
Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10
Other Recalls from Parker Laboratories, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1604-2024 | Class II | Redux Electrolyte Creme, Product Ref. 66-04. H... | Mar 22, 2024 |
| Z-1204-2024 | Class II | Tensive Conductive Adhesive Gel, Product Ref. 2... | Jan 22, 2024 |
| Z-1777-2018 | Class II | Sterile Aquasonic 100 Ultrasound Transmission G... | Apr 13, 2017 |
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.