Arrow Arterial Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
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 is classified as FDA Class II and involves reports of needlestick injuries, which aligns with the rubric criteria for a Severe rating involving significant injury reports.
Plain-English summary
Arrow International is recalling Arterial Catheterization Kits, specifically material number ASK-04500-HFH2, due to reports of safety cover disengagement and needlestick injuries. The issue involves the BD Eclipse Needle packaged with certain Arrow products.
The recall affects 43,394 devices that were distributed nationwide. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International for instructions on how to return or dispose of the devices.
The recalled product
- Product
- Arterial 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-04500-HFH2
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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