Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error
Arrow International Inc. is recalling 3,143 Pediatric Two-Lumen Central Venous Catheterization Kits due to a labeling error on the lidstock.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error, which fits the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Arrow International Inc. is recalling 3,143 units of the Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter (REF AK-25502). The product is used to provide short-term central venous access for patients requiring treatment of diseases or conditions necessitating such access.
The recall was initiated because of a labeling error on the lidstock. Specifically, the lidstock displays the catheter cross-section of the gauge (GA) values in a reversed manner. This error could potentially lead to confusion regarding the specific gauge of the catheter being used.
The affected units were distributed nationwide in the United States. The specific lot numbers involved are 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, and 13F18G0480. Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected kits if found.
The recalled product
- Product
- Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 3,143
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 (9)
- Lot/Batch Numbers: 13F18C0374
- 13F18H0580
- 13F18D0504
- 13F18L0507
- 13F18E0380
- 13F18L0714
- 13F18G0180
- 13F18L0936
- 13F18G0480
Distribution
Distributed nationwide across the United States.
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