Arrow Arterial Line Kits Recalled for Needlestick Injury Risk
Arrow International is recalling Arterial Line Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
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 involves a Class II medical device with reported needlestick injuries, which constitutes a significant injury report under the severity rubric.
Plain-English summary
Arrow International is recalling Arterial Line Kits with Sharps Safety Features and Maximal Barrier Precautions. The recall is initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle packaged with certain Arrow products.
The affected product is the Arrow Arterial Catheterization device, which permits access to the peripheral arterial circulation or other small vessels. The specific material number for the recalled items is ASK-04510-MM3. The firm reports that a total of 43,394 devices were distributed nationwide.
Healthcare facilities and users should stop using the affected Arrow Arterial Line Kits immediately. Users should contact Arrow International for instructions on how to return or dispose of the recalled devices to prevent further needlestick injuries.
The recalled product
- Product
- Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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-04510-MM3
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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