Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Sterility Concerns
Arrow International is recalling VPS Rhythm ECG Accessory Packs with Johans Adapters 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, and the hazard involves a potential sterility compromise without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc is recalling 416,055 units of VPS Rhythm ECG Accessory Packs with Johans Adapters (Product code: RHY-100-ECGJ). The recall is due to a potential compromise in product sterility caused by unsealed packaging.
The affected products were distributed in the United States and internationally, including Australia, Canada, the United Kingdom, and numerous other countries. Specific lot numbers involved in the recall are 13F17A0120, 13F17A0287, 13F17C0018, 13F17D0136, and 13F17E0122.
Healthcare providers and consumers should stop using these specific accessory packs and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — ECG Accessories
- Affected units
- 416,055
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 Numbers: 13F17A0120 13F17A0287 13F17C0018 13F17D0136 13F17E0122
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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