Arrow International Recalls Central Venous Catheters With Incorrect Guide
Arrow International Inc. is recalling 5,926 ARROWg+ard Blue Plus Multi Lumen CVC kits that 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 does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc. is recalling 5,926 units of ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter) kits. The affected products have Product Code AK-45703-ACDC and expiration dates ranging from February 2018 to November 2018. The specific lot numbers involved are 13F17C0102 and 13F16M0264.
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 check their inventory for these specific lot numbers and expiration dates. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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 numbers: 13F17C0102 and 13F16M0264
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.
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