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FDA (Device enforcement)Recalled 2021-10-08closedclass ii

Civco Medical Instruments Co. Inc.: VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

Is my product affected?

VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

  • UPC 00841436101936

Check against the official notice below — it lists the full affected range.

What happened

Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtuTRAX due to a potential defect where the device may not tighten properly onto the instrument it is designed to secure. The recalled units were distributed worldwide, including across the United States and in Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand. The recall involves 18 boxes containing 5 units each, identified by Part Number 610-1080, UDI 00841436101936, and specific lot numbers ranging from A109102 through A141818.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Details from the source

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: 18 boxes (5 units/box) Lot/code info: Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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