FlexDex 8mm Needle Driver Damaged Packaging Inspection Guidance
FlexDex Inc. is reinforcing instructions for the 8mm FlexDex Needle Driver (Product Code FD-335 ND). Users should not use the product if packaging shows any damage, including pinholes or tears.
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 an FDA Class II medical device with no reported illnesses or injuries. The hazard is theoretical—damaged packaging could compromise sterility—and the firm response is instructional rather than mandatory removal, making this a low-risk precautionary recall.
Plain-English summary
The 8mm FlexDex Needle Driver, Product Code FD-335 ND, manufactured by FlexDex Inc., is the subject of a reinforced instruction notice affecting 273 distributed units.
FlexDex is emphasizing instructions from the product's Instruction For Use (IFU) regarding packaging inspection. The firm states that the product should not be used if any packaging damage is observed, including pinholes or tears.
Package damage could compromise the sterile integrity of the device, which could affect its safety and performance in surgical use.
If you have received this product, inspect the packaging carefully before use. Do not use the needle driver if you observe any damage to the package, including pinholes or tears.
The recalled product
- Product
- 8mm FlexDex Needle Driver, Product Code FD-335 ND
- Manufacturer
- FlexDex Inc.
- Affected units
- 273
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 (1)
- All lots
Distribution
Distribution scope not specified by the agency.
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