Arrow Multi Lumen CVC Kit Recalled for Incorrect Springwire Guide
Arrow International Inc. is recalling 5,926 Arrow Multi Lumen CVC Kits because they may contain the incorrect Springwire Guide.
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, and the source text describes a component mismatch (incorrect Springwire Guide) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Arrow International Inc. is recalling 5,926 units of the Arrow Multi Lumen CVC Kit (Central venous catheter), Product Code CDC-15703-1A. The affected units have expiration dates ranging from February 2018 to November 2018 and are identified by Lot number 13F16M0241.
The recall was initiated because these finished good kits may contain the incorrect Springwire Guide (SWG). The products were distributed nationwide in the United States.
Healthcare facilities and consumers should stop using these specific kits and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 5,926
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)
- Lot number: 13F16M0241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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 12 products in this recall →Related recalls
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Similar recalls
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