Recall Z-0237-2019 ยท GEN Forceps, General & Plastic Surgery
Micro-Tech (Nanjing) Co., Ltd.
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
| Date | Sep 20, 2018 |
| Status | Terminated |
| Reason | Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units |
| Root cause | Under Investigation by firm |
| Action | On September 20, 2018 Micro-Tech (Nanjing) Co., Ltd emailed their US distributor advising them of a recall. On September 20,2018, Micro-Tech Endoscopy issued URGENT MEDICAL DEVICE RECALL notices to all U.S. customers. On October 15, 2018, Micro-Tech Endoscopy issued AMENDED URGENT MEDICAL DEVICE RECALL notices to all U.S. customers. The following are Actions To Be Taken By Customers: - Inspect stock and quarantine products subject to recall - Customers with products quarantined & subject to recall should Return the completed Recall Return Response Acknowledgement and Receipt Form via Fed Ex |
| Quantity | 1360 pcs |
| Distribution | US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.