Arrow Arterial Catheterization Kit Recalled for Potential Sterility Compromise
Arrow International is recalling Arterial Catheterization Kits because packaging defects may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential compromise of sterility in a medical device used for arterial access, which poses a risk of infection (risk-of-harm) without reported injuries in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International is recalling Arterial Catheterization Kits, also known as Arterial Line Kits with Sharps Safety Features, due to a potential packaging defect. The recall was initiated because the packaging may not be completely sealed, which could compromise the sterility of the medical devices.
The affected products are identified by material numbers ASK-04018-CC, ASK-04510-HUM, and ASK-04550-UHC, and are associated with Device Listing D025180. The recall covers 27,485 units distributed in the United States and 4,371 units distributed internationally, with distribution patterns including nationwide US distribution and Canada.
Healthcare providers and facilities should check their inventory for these specific material numbers and stop using the affected kits. Consumers are advised to contact their healthcare provider if they have recently received an arterial line using this specific product. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
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 (4)
- Material number: ASK-04018-CC
- ASK-04510-HUM
- ASK-04550-UHC
- Device Listing D025180
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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 12 products in this recall →Related recalls
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