Arrow International Recalls Central Venous Catheter Kits Missing Safety Checklists
Arrow International is recalling 18,124 Pressure Injectable Multi-Lumen CVC Kits because they lack required clinical safety 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, but the source text describes a missing documentation issue (checklists) rather than a physical defect or reported injury, aligning with the 'Minor labeling errors' or 'voluntary precautionary' criteria for a Moderate severity score.
Plain-English summary
Arrow International Inc is recalling 18,124 units of the Pressure Injectable Multi-Lumen CVC Kit. The recall was initiated because the products do not contain the Central Venous Catheter Placement Procedures Note or 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 associated with this recall is CDC-15703-P1A 13F16J0336.
Healthcare facilities and consumers should check their inventory for this specific product code. If found, the products should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the missing safety documentation may impact clinical best practices.
The recalled product
- Product
- Pressure Injectable Multi- Lumen CVC Kit
- 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)
- CDC-15703-P1A 13F16J0336
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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