Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, e...
FDA Device Recall #Z-1005-2015 — Class II — December 16, 2014
Recall Summary
| Recall Number | Z-1005-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 16, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arrow International Inc |
| Location | Reading, PA |
| Product Type | Devices |
| Quantity | 420 |
Product Description
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Reason for Recall
the Instructions for Use (IFU) were inadvertently removed from the kit.
Distribution Pattern
In the state of KY
Lot / Code Information
Multi-Lumen PI CVC Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015 PSI Kit: 8.5 FR X 4-1/8 (10 CM), product code ASK-09803-OSU2 , lot #23F14C1014, exp. 31-Aug-2015:
Other Recalls from Arrow International Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0231-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0232-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0234-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0233-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-2071-2021 | Class II | Arrow Temporary Pacing Catheter/Introducer Kit ... | May 19, 2021 |
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.