Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves reported needlestick injuries, which constitute significant injury reports, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Arrow International Inc. is recalling the Radial Artery Catheterization Kit with Sharps Safety Features. The recall is initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle that is packaged with certain Arrow products.
The affected product is identified by material number ASK-04020-MHT. The firm reports that a total of 43,394 devices were distributed nationwide. The Arrow Arterial Catheterization device is designed to permit access to the peripheral arterial circulation or to other small vessels.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International for further instructions or replacement.
The recalled product
- Product
- Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheterization
- 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-04020-MHT
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.
See all 56 products in this recall →Related recalls
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