Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error
Arrow International is recalling 166 kits of pediatric central venous catheters because the packaging incorrectly identifies the catheter length.
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, but the source explicitly states no patient injuries have been reported and the hazard is a labeling error, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
Arrow International Inc. is recalling 166 units of the Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Catalog Number AK-22502. The recall involves a specific lot identified by code 13F17K0202. The product is a medical device used to provide venous access to the central circulation of pediatric patients.
The recall is due to a labeling error. The product code AK-22502 contains a 2-lumen, 5 Fr x 5 cm catheter. However, the lidstock packaging incorrectly labels the product as AK-25502, which indicates it contains a 2-lumen, 5 Fr x 8 cm catheter. This discrepancy could lead to the use of the wrong catheter size if the packaging is relied upon without verifying the actual product code.
The affected units were distributed to distributors in Missouri and Utah, and to medical facilities in Alabama, California, Illinois, Massachusetts, New Hampshire, New Mexico, New York, Texas, Virginia, and Wisconsin. No patient injuries have been reported related to this issue. Healthcare providers should verify the product code on the catheter itself rather than relying solely on the lidstock label.
The recalled product
- Product
- Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 166
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)
- 13F17K0202
Distribution
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