Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (P...
FDA Device Recall #Z-0237-2019 — Class II — September 20, 2018
Recall Summary
| Recall Number | Z-0237-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 20, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Micro-Tech (Nanjing) Co., Ltd. |
| Location | Nanjing, N/A |
| Product Type | Devices |
| Quantity | 1360 pcs |
Product Description
Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
Reason for Recall
Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
Distribution Pattern
US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C.
Lot / Code Information
Lot Number - M180409031 Date of Manufacture - 20180409 Use By - 20220408
Other Recalls from Micro-Tech (Nanjing) Co., Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1877-2018 | Class II | Trident Endoscopic Ultrasonic Biopsy Needle (FNB) | Mar 12, 2018 |
| Z-1878-2018 | Class II | Trident Endoscopic Ultrasonic Aspiration Needle... | Mar 12, 2018 |
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.