Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists
Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required procedural notes and insertion checklists.
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 involves missing documentation (procedural notes and checklists) rather than a physical defect in the device or a direct contamination risk, fitting the criteria for moderate severity.
Plain-English summary
Arrow International Inc is recalling 18,124 units of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter. The recall is due to the absence of the Central Venous Catheter Placement Procedures Note and the Central Line Insertion Checklist, which are intended to guide clinicians in using best practices during central line insertions.
The affected products were distributed nationwide. The recall number is Z-1163-2018. The source text does not specify specific dates of distribution or identify specific facilities affected.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International Inc for further instructions or a replacement. The missing documentation is a tool for clinical guidance rather than a defect in the catheter itself.
The recalled product
- Product
- Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- 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-45703-PUR1 23F16H0385
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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