Arrow International Recalls VPS TipTracker Stylet Accessories Due to Packaging Defects
Arrow International is recalling VPS TipTracker Stylet Accessories because unsealed packaging may compromise product sterility.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential sterility compromise due to packaging, which fits the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc is recalling the VPS TipTracker Stylet Accessory (Product code: RHY-177-TTSAP) due to a potential sterility issue. The recall is necessary because unsealed packaging may have compromised the sterility of the medical devices.
A total of 416,055 units are affected by this recall. The products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe and Asia.
Healthcare providers and consumers should stop using the recalled VPS TipTracker Stylet Accessories immediately. Users should check their inventory for the specific lot numbers listed in the official recall notice and contact Arrow International Inc for further instructions on returns or replacements.
The recalled product
- Product
- VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 recalled by Arrow International 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.
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