Arrow International Recalls PIC Catheters Due to Labeling Error
Arrow International is recalling 1,351 CG+ Arrow PIC Catheters due to a labeling error where lidstock and banner card codes do not match.
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 due to a labeling error. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are categorized as Moderate (Score 2).
Plain-English summary
Arrow International, Inc. is recalling 1,351 CG+ Arrow PIC Catheters, also known as Antimicrobial/Antithrombogenic PICC Kits, due to a labeling error. The recall affects specific lot numbers: 23F16C0851, 23F16A0727, and 23F16C0844.
The issue involves a discrepancy between the lidstock and the banner card on the kit packaging. Some kits display the code CDC-45541-HPK1A on the lidstock but CDC-45052-HPK1A on the banner card, while others may have these codes reversed. This mismatch could cause confusion regarding the specific product identification.
The affected devices were distributed in the United States. Arrow International has notified customers who received the affected kits. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 1,351
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 (2)
- Device Listing Number: D149129 Lot Numbers: 23F16C0851
- 23F16A0727 and 23F16C0844
Distribution
Distribution scope not specified by the agency.
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