Arrow International Recalls Femoral Arterial Line Catheterization Kits
Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of needlestick injuries, which aligns with the rubric criteria for Severe severity (FDA Class II with injury reports).
Plain-English summary
Arrow International Inc. has initiated a recall of the Femoral Arterial Line Catheterization Kit, identified by material number ASK-04018-ST. The recall involves 43,394 devices that were distributed nationwide.
The recall was initiated due to reports of safety cover disengagement and needlestick injuries involving the BD Eclipse Needle, which is packaged with certain Arrow products. The Arrow Arterial Catheterization device is designed to permit access to the peripheral arterial circulation or other small vessels.
Healthcare facilities and consumers should stop using the affected kits immediately. Users should contact Arrow International Inc. for further instructions on how to return or dispose of the recalled devices.
The recalled product
- Product
- Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
- Manufacturer
- Arrow International Inc
- Affected units
- 43,394
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)
- Material number ASK-04018-ST
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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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