Bedford, MA, United States
Ninepoint Medical Inc. recalls
1 recall recorded since 2018, most recently on 11 April 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 April 2018
- Terminated
- 20 August 2018
- Reason
- Distal tips of the probes may detach from the probe shaft during use.
- Distribution
- US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, MA, NJ, NM, NY, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1781-2018
- NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)00527
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.