Arrow International Recalls Two-Lumen Central Venous Access Kits
Arrow International is recalling Two-Lumen Central Venous Access Kits because packaging may not be completely sealed, potentially compromising 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. The hazard is a potential compromise of sterility due to packaging issues, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
Arrow International is recalling the Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter. The recall is being conducted because the packaging for these devices may not be completely sealed, which may compromise the sterility of the product.
The affected product is identified by Material number CDC-11242-1A and Device Listing D025760. A total of 27,485 units were distributed in the U.S. and 4,371 units were distributed internationally. The distribution pattern includes nationwide distribution in the U.S. and Canada.
This recall is classified as Class II by the U.S. Food and Drug Administration. Consumers and healthcare providers should stop using the affected devices and contact Arrow International for further instructions.
The recalled product
- Product
- Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
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: CDC-11242-1A Device Listing D025760
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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Similar recalls
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