SpineNet Bone Marrow Aspiration Needle Kit Recalled for Lack of FDA Clearance
SpineNet is recalling 100 units of Bone Marrow Aspiration Needle Kits because they were marketed for use with the SpineNet ACC device without FDA clearance or approval.
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 classified as FDA Class II. The hazard involves marketing a device without clearance, which is a regulatory compliance issue rather than a direct physical defect causing injury, fitting the Moderate severity criteria for labeling or regulatory issues without reported harm.
Plain-English summary
SpineNet is recalling 100 units of the SpineNet Bone Marrow Aspiration Needle Kit (Ranfac Bone Marrow Aspiration Needle #74150-01M). The affected lots are #22754F16 and #25854I17. The device is used to aspirate bone marrow.
The recall was initiated because SpineNet was marketing this device to be used with the SpineNet ACC device without FDA clearance or approval. The agency classification for this recall is Class II.
The product was distributed to one customer in Florida. Consumers and healthcare providers should stop using the affected units and contact SpineNet for further instructions.
The recalled product
- Product
- SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
- Manufacturer
- SpineNet
- Affected units
- 100
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)
- Lot # 22754F16 and #25854I17
Distribution
Distributed in 1 state:
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