Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error
Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.
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 involves a minor labeling error regarding shipping cartons, which fits the criteria for a moderate severity score.
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 because of 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 products were distributed in the United States in the states of Tennessee and Kentucky. The Arrow arterial catheterization device is used to permit access to the peripheral arterial circulation.
Consumers and healthcare facilities should check their inventory for these specific lot numbers and material codes. If the product is found, it should be removed from use and returned to the manufacturer or the supplier from whom it was purchased.
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
- 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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