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

Civco Medical Instruments Co. Inc.: VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

Is my product affected?

VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

  • UPC 00841436102285

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, 14 Ga VirtuTRAX device due to a potential defect where the device may not tighten properly onto the instrument intended for use. The affected product was 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 45 units across 9 boxes were involved in the recall, specifically those with Part Number 610-1153, UDI 00841436102285, and Lot Numbers A122182, A131167, A131689, A131691, or A141823.

The source document does not specify a remedy or instructions for what affected consumers should do regarding 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: 9 boxes (5 units/box) Lot/code info: Part Number 610-1153; UDI 00841436102285; Lot Numbers: A122182, A131167, A131689, A131691, A141823

Source

Official record: FDA (Device enforcement) ↗

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

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