Arrow Arterial Line Kit Recalled for Potential Sterility Compromise
Arrow International is recalling Arterial Line Kits because unsealed packaging may compromise product sterility. The recall covers 416,055 units distributed in the US and 33 other countries.
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 3/5 (High).
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 involves a medical device where sterility may be compromised, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling Arterial Line Kits with Sharps Safety Features and Maximal Barrier Precautions (Product Code: ASK-04018-OH1). The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The recall involves 416,055 total products. The affected lot numbers are 13F17E0562, 13F17G0537, 13F17K0188, and 13F17L0167. These products were distributed in the United States and 33 other countries, including Australia, Canada, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
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)
- Lot Numbers: 13F17E0562 13F17G0537 13F17K0188 13F17L0167
Distribution
Part of a larger recall action
This product is one of 76 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 76 products in this recall →Related recalls
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