Arrow-Johans ECG Adapter Recalled for Potential Sterility Compromise
Arrow International Inc. is recalling 416,055 ECG adapters because unsealed packaging may compromise product sterility.
What this means for you
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 is a theoretical risk of sterility compromise due to packaging issues without reported injuries or illnesses.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of the Arrow-Johans ECG Adapter for Right Atrial Electrocardiography (RAECG), Product Code EG-04900. 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 numerous international locations, including Australia, Canada, and the United Kingdom. The specific lot numbers involved are 13F17C0326, 13F17E0123, 13F17F0584, 13F17G0519, and 13F17H0292.
Healthcare providers and consumers should stop using these specific adapters and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900
- Manufacturer
- Arrow International Inc
- 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: 13F17C0326 13F17E0123 13F17F0584 13F17G0519 13F17H0292
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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