Verathon Recalls GVL 2 Stat Blades Packaged with Incorrect Size
Verathon is recalling GVL 2 Stat blades (lot GC32825) because they were physically packaged with the incorrect size device, GVL 1 Stat blades.
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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported in the source text, and the hazard is primarily a packaging/labeling error.
Plain-English summary
Verathon Inc is recalling GVL 2 Stat blades, lot GC32825, because the product was physically packaged with the incorrect size device, specifically GVL 1 Stat blades. The affected products include Part Number 0270-0429 (GVL 2 Stat, box of 10), Part Number 0574-0027 (GVL 2 Stat, single pouched), and Part Number 0270-0662 (GlideScope AVL Video Baton 1-2 Kit). The GVL 2 Stat is recommended for patients with a weight between 4 and 22 lbs (1.8-10 kg).
The recall involves a total of 292 boxes, distributed worldwide to the United States, Canada, Chile, Mexico, Panama, the Philippines, Qatar, South Africa, and The Netherlands. This is a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and consumers should stop using the affected GVL 2 Stat blades and contact Verathon Inc for further instructions or a replacement. The incorrect packaging may lead to the use of a device size that is not appropriate for the patient's weight and size, potentially affecting the safety and efficacy of the procedure.
The recalled product
- Product
- It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part…
- Manufacturer
- Verathon Inc
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 GC32825
Distribution
Distributed nationwide across the United States.
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