Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is...
FDA Device Recall #Z-2243-2016 — Class II — June 2, 2016
Recall Summary
| Recall Number | Z-2243-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 2, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Parker Medical |
| Location | Highlands Ranch, CO |
| Product Type | Devices |
| Quantity | 5,500 units |
Product Description
Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.
Reason for Recall
Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.
Distribution Pattern
US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
Lot / Code Information
Model Number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90 Lot Numbers: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O); 1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N,O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N,O)
Other Recalls from Parker Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1399-2017 | Class II | Parker Left Double Lumen Endobronchial Tube wit... | Dec 16, 2016 |
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.