Vidacare EZ-IO Needle Set Recalled for Specification Failures
Vidacare Corporation is voluntarily recalling 172 units of EZ-IO 45mm Needle Sets because they do not meet specifications.
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: The recall is voluntary and precautionary due to a failure to meet specifications, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Vidacare Corporation is voluntarily recalling 172 units of the EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005, lot code 3606455. The recall is being conducted because the needle sets do not meet their specifications.
The affected products were distributed nationwide in the United States and internationally to Canada. The source text does not specify the exact number of units distributed in each location or the specific nature of the specification failure.
Consumers and healthcare providers should stop using the affected needle sets and contact Vidacare Corporation for further instructions or a replacement.
The recalled product
- Product
- EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
- Manufacturer
- Vidacare Corporation
- Category
- Medical Device — Needle Set
- Hazard
- Affected units
- 172
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 (2)
- Part number 9079-VC-005
- lot code 3606455
Distribution
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