Arrow International Recalls Two-Lumen Central Venous Access Kits
Arrow International Inc. is recalling 416,055 Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Arrow International Inc. is recalling 416,055 units of the ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters. The recall is due to a defect where product sterility may be compromised by unsealed packaging.
The affected product is identified by Product Code ASK-21142-WHC2 and specific lot numbers: 13F17E0597, 13F17F0395, 13F17K0120, and 13F17L0532. The FDA has classified this recall as Class II.
The products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas. Healthcare facilities and distributors should check their inventory for the affected lot numbers and stop using the products if the packaging is unsealed.
The recalled product
- Product
- ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
- 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: 13F17E0597 13F17F0395 13F17K0120 13F17L0532
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.
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