VirtuTRAX Instrument Navigator recalled for potential tightening failure
Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential defect that may prevent proper tightening onto medical instruments. The device was distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall with no reported injuries or illnesses. The device may fail to tighten properly onto instruments, representing a functional defect without documented harm.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling the VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX. The recall is prompted by a potential defect in which the device may not tighten properly onto the instrument it is designed to secure.
The affected devices were distributed in the United States and internationally to Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, and Thailand. The recall includes 45 units total distributed across 9 boxes (5 units per box). Affected lot numbers are A122182, A131167, A131689, A131691, and A141823.
The recalled product
- Product
- VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Category
- Medical Device
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Part Number 610-1153
- UDI 00841436102285
- Lot Numbers: A122182
- A131167
- A131689
- A131691
- A141823
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Civco Medical Instruments Co. Inc.
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