Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guidance Documents
Arrow International is recalling 18,124 central venous catheterization kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.
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 involves missing documentation rather than a physical defect or contamination, fitting the 'Minor labeling errors' or 'documentation issues' criteria for a Moderate severity score.
Plain-English summary
Arrow International Inc is recalling 18,124 units of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter. 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-15703-PWBH 13F16K0166. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers should check their inventory for this specific product code. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Clinicians should ensure they have access to the missing procedural 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 Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the 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-15703-PWBH 13F16K0166
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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