Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Sterility Concerns
Arrow International Inc is recalling VPS Rhythm ECG Accessory Packs because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 35 other countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (compromised sterility) in a medical device, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling VPS Rhythm ECG Accessory Packs (Product code: RHY-100-ECGO) because the product sterility may be compromised due to unsealed packaging. The recall involves 416,055 total products, specifically Lot Number 13F17A0288.
The affected products were distributed nationwide in the United States and in 35 other countries, including Australia, Canada, the United Kingdom, and Germany. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare facilities should stop using the affected ECG accessory packs and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
- 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: 13F17A0288
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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