Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide
Arrow International is recalling specific lots of ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization 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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 5,926 units of the Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit. The recall affects product codes ASK-45703-PNHS, ASK-45703-PGMCL, and ASK-45703-PNW with expiration dates ranging from February 2018 to November 2018. The specific lot numbers involved are 23F16M0498, 23F17A0505, and 23F17B0116.
The recall was initiated because these finished good kits may contain the incorrect Springwire Guide (SWG). The affected products were distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected kits and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 5,926
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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