VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Check against the official notice below — it lists the full affected range.
Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtuTRAX due to a potential defect where the device may not tighten properly onto the instrument it is designed to secure. The affected products were distributed worldwide, including throughout the United States and in Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand. A total of 52 boxes containing 5 units each are affected, identified by Part Number 5350925, UDI 00841436100892, and specific lot numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, and A142178.
The source document does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Reason for recall: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand. Quantity: 52 boxes (5 units/box) Lot/code info: Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.