B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252...
FDA Device Recall #Z-0509-2021 — Class II — March 23, 2020
Recall Summary
| Recall Number | Z-0509-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 23, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Janus Trade Group |
| Location | Eatontown, NJ |
| Product Type | Devices |
| Quantity | 1365 cases (200 units/case) |
Product Description
B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
Reason for Recall
Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.
Distribution Pattern
US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.
Lot / Code Information
Lots 18L23G8271 17A20G8273 18M02G8315 16H16G8261 18K18G8244 17D08G8241 16H16G8261 15H25G8315 18G15A272 18G31G8316 18G31G8392 17H20G8391 18M02G8315 18M02G8315 18F29G8362 18D01G8273 17K08G8272 17K08G8273 17G10G8261 19A12G8272 19A12G8272 18H17G8272 18H17G8272 18F26G8303 18H04G8261 15F25G8395 17K27G8304 17C16G8304 17H02G8392 17F15G8302 17M10G8271 17M10G8273 17M15G8261 17C17G8302 17C18G8305 18M20G8271 18L29G8271 18K08G8263 18HI8G8243 18F25G8272 18F25G8272 17M11G8273 17H23G8272 17H23G8271 17H23G8271 18L23G8271 18L23G8271 17A20G8273 17A20G873 17A20G8273 17D08G8241 17D08G8241 17D08G8241 16N24G8303 16H30G8303 16H30G8304 16L0G8275 14N10G8274 16H16G8261
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.