Recall Z-0237-2019
Micro-Tech (Nanjing) Co., Ltd. · initiated September 20, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Number - M180409031 Date of Manufacture - 20180409 Use By - 20220408
Reason for recall
Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
FDA-determined cause: Under Investigation by firm
Action taken
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 account provided - Do not return USED devices - Customers who DO NOT have devices subject to call are advised to return the completed Recall Return Response Acknowledgement and Receipt Form via email to Quality@mtendoscopy.com Customers with questions may contact Angela Smith 1-877-552-4027
Details
- Recall number
- Z-0237-2019
- Initiated
- September 20, 2018
- Terminated
- October 21, 2019
- Product code
- GEN – Forceps, General & Plastic Surgery
- 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.
- Recalling firm
- Micro-Tech (Nanjing) Co., Ltd., Nanjing National Nanjing