Arrow Bipolar Electrode Catheter Recalled for Incorrect Expiration Date Labeling
Arrow International Inc. is recalling 7 units of a specific bipolar electrode catheter lot because they are labeled with an incorrect expiration date.
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 specific defect is a labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Arrow International Inc. is recalling 7 units of the ARROW Bipolar Electrode Catheter with shrouded pins, 6 Fr, 110 cm (Product Code: AI-06210-S). The recall is limited to Lot Number 16F18A0010, which has a use-by date of December 31, 2023. These products were distributed in Pennsylvania.
The recall was initiated because the products are labeled with an incorrect expiration date. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare facilities should stop using the affected catheters and contact Arrow International Inc. for further instructions or a return.
The recalled product
- Product
- ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 7
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/Batch Number:16F18A0010 Use By: 2023-12-31
Distribution
Distributed in 1 state:
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