Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TA...
FDA Device Recall #Z-2288-2020 — Class II — May 8, 2020
Recall Summary
| Recall Number | Z-2288-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 8, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arrow International Inc |
| Location | Reading, PA |
| Product Type | Devices |
| Quantity | 109 eaches (US), 23,021 (OUS) |
Product Description
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Reason for Recall
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Distribution Pattern
US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.
Lot / Code Information
Lots: (Dist'd in US) 23F19A0260 23F19M0224 23F19E0120 23F19L0014 23F19B0184 (Dist'd OUS) 71F19M0710 71F18K1579 71F18F1429 71F18J2111 71F20A1078 71F20A1614 71F19E2019 71F19L0269 71F19L2068 71F19K1049 71F19K2042 71F19L0977 71F19M1319 71F20A0805 71F20A0812 71F20A0813 71F19J0604 71F19K1653 71F19K2501 71F19M0326 71F20A1819 71F20A2040 71F20A0044 71F19K2043 71F19L0359
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.