Arrow Recalls Antimicrobial Central Venous Catheters Due to Labeling Error
Arrow International is recalling 170 units of Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheters because the lidstock incorrectly lists the catheter length as 16CM instead of 20CM.
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 involves a minor labeling error regarding product dimensions, which fits the rubric criteria for moderate severity.
Plain-English summary
Arrow International Inc is recalling 170 units of the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC, lot RF2110924. The recall was initiated due to a labeling inconsistency on the product packaging.
The lidstock for the affected units contains conflicting information regarding the catheter dimensions. One portion of the lidstock states that the kit contains an 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM.
The affected products were distributed in the United States, including the states of Iowa, Oregon, West Virginia, Michigan, Arizona, Illinois, Pennsylvania, Georgia, Delaware, North Carolina, Louisiana, and Virginia. Consumers and healthcare facilities should stop using the affected units and contact Arrow International for further instructions.
The recalled product
- Product
- Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 170
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 RF2110924
Distribution
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