Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guides
Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical procedure notes and checklists.
What this means for you
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 hazard is a missing documentation tool rather than a direct physical defect or contamination, fitting the criteria for moderate severity involving minor labeling or documentation issues.
Plain-English summary
Arrow International Inc is recalling 18,124 units of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip. The recall is due to the absence of the Central Venous Catheter Placement Procedures Note and the Central Line Insertion Checklist. These documents are intended to guide clinicians in using best practices during central line insertions.
The affected products were distributed nationwide. The specific product code is ASK-42703-PSCH 23F16H0492. This recall is classified as Class II by the FDA, indicating a situation where use of the product might cause temporary or medically reversible health consequences.
Healthcare facilities and distributors should stop using the affected kits and contact Arrow International for instructions on how to return the products. Clinicians should ensure they have access to the appropriate procedure notes and checklists to maintain best practices during central line insertions.
The recalled product
- Product
- Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 18,124
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)
- ASK-42703-PSCH 23F16H0492
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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