WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascu...
FDA Device Recall #Z-1703-2016 — Class II — April 26, 2016
Recall Summary
| Recall Number | Z-1703-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 26, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | B. Braun Medical, Inc. |
| Location | Allentown, PA |
| Product Type | Devices |
| Quantity | 5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)] |
Product Description
WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.
Reason for Recall
Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Distribution Pattern
Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.
Lot / Code Information
Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.
Other Recalls from B. Braun Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1021-2025 | Class II | Design Options COMBINED SPINAL/EPIDURAL TRAY- ... | Dec 4, 2024 |
| Z-3144-2024 | Class II | AET36 ANESTH EXT SET - Anesthesia Extension Set... | Aug 8, 2024 |
| Z-2387-2024 | Class II | Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-U... | Jun 17, 2024 |
| Z-2380-2024 | Class II | Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE... | Jun 17, 2024 |
| Z-2391-2024 | Class II | Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE... | Jun 17, 2024 |
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.