Nanjing, China
Micro-Tech (Nanjing) Co., Ltd. recalls
2 recalls recorded since 2018, most recently on 20 September 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 September 2018
- Terminated
- 21 October 2019
- Reason
- Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
- Distribution
- US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0237-2019
- 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
Terminated Class II Medical devices
- Recall started
- 12 March 2018
- Terminated
- 30 August 2018
- Reason
- The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.
- Distribution
- US distribution to one distributor in MI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1877-2018, Z-1878-2018
- Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
- Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.