Arrow International Recalls Central Venous Catheter Kits Due to Labeling Error
Arrow International is recalling 65 Multi-Lumen Central Venous Catheterization Kits because the outer shipping box displays an incorrect expiration date. The kits inside are correctly labeled and pose no risk to patients.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging-only labeling error on the outer box, with the source text explicitly confirming that the inner kits are correctly labeled and there is no risk to the patient.
Plain-English summary
Arrow International, Inc. has initiated a voluntary recall of 65 Multi-Lumen Central Venous Catheterization Kits (Catalog No. AK-12703, Lot Number RF3039028). The recall was triggered because the label on the outer corrugate shipping box displays an incorrect expiration date.
The source text explicitly states that all kits packaged within the corrugate are correctly labeled with the proper expiration date. Consequently, there is no risk to the patient associated with this recall.
The affected products were distributed in the United States, including the states of Maryland, North Carolina, Louisiana, Indiana, Ohio, Kentucky, California, Pennsylvania, New York, and Nevada. Consumers and healthcare facilities should check their inventory for this specific lot number and contact the manufacturer for instructions on returning the product.
The recalled product
- Product
- Multi-Lumen Central Venous Catheterization Kit
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 65
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)
- Catolog No - AK-12703 lot number RF3039028
Distribution
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