Arrow Central Venous Catheterization Kit Recalled for Incorrect Banner Card
Arrow International Inc is recalling 231 units of 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kits because they may contain the incorrect banner card.
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, but the specific defect is a labeling error (incorrect banner card) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Arrow International Inc is recalling 231 units of Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kits (Product Code: AK-42854-P1A, Lot Number: 13F18H0499). The recall was initiated because the products may contain the incorrect banner card within the kit.
These medical devices are intended to permit venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The affected units were distributed nationwide in the United States.
The FDA has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected kits and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 231
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 Number: 13F18H0499
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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