Arrow Recalls Femoral Arterial Catheterization Kits Due to Labeling Error
Arrow International Inc is recalling 50 femoral arterial catheterization kits because some shipping cartons contained the wrong product model.
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 involves a minor labeling error where the wrong product model was shipped in the carton, which fits the rubric for moderate severity.
Plain-English summary
Arrow International Inc is recalling 50 units of the Femoral Arterial Line Catheterization Kit with Sharps Safety Features (Material ASK-04018-VUH). The recall was initiated due to a labeling error where some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits, and some cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
The affected products are identified by lot numbers 23F14M0829 and 23F14M0986. These kits were distributed in the United States, specifically in the states of Tennessee and Kentucky. The Arrow arterial catheterization device is used to permit access to the peripheral arterial circulation.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International Inc for instructions on how to return the product.
The recalled product
- Product
- Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 50
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 (2)
- Lot/Batch Numbers: 23F14M0829
- 23F14M0986
Distribution
Part of a larger recall action
This product is one of 2 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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