Arrow International Recalls Central Venous Catheter Kits Missing Safety Checklists
Arrow International is recalling 18,124 central venous catheter kits because they lack required safety checklists and procedure notes.
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 hazard is a missing documentation tool rather than a physical defect or contamination. Since no injuries or illnesses are reported and the risk is theoretical (procedural error due to missing guidance), it fits the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
Arrow International Inc is recalling 18,124 units of the ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. These medical devices are intended to permit venous access to the central circulation. The recall is due to the absence of the Central Venous Catheter Placement Procedures Note and the Central Line Insertion Checklist, which are tools intended to guide clinicians in using best practices during central line insertions.
The affected products were distributed nationwide. The specific lot codes involved are CDC-42703-P1A, CDC-45703-P1A, 13F16H0215, 13F16H0216, 13F16J0157, 13F16J0053, 13F16J0182, 13F16J0186, 13F16K0119, and 13F16K0266.
Healthcare facilities should check their inventory for these specific lot codes and stop using the affected kits. Clinicians should ensure they have access to the missing safety documentation or utilize alternative best-practice guidelines to mitigate the risk of procedural errors during central line insertion.
The recalled product
- Product
- ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 18,124
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.
See all 9 products in this recall →Related recalls
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