Arrow CVC Kit Recall for Missing Lot and UDI Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.
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 missing labeling/documentation (lot, expiration, UDI) rather than a direct physical defect or reported injury, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Arrow International Inc is recalling 23,904 units of the ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit. The recall was initiated because some of the products may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
The affected products were distributed in the United States in the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. The specific lot codes associated with the recall are CDA-45854-P1A, 13F17C0325, 13F17D0283, and 13F17F0748.
This is a Class II recall. The missing stickers prevent the verification of the product's identity and expiration status, which is a documentation and labeling issue rather than a direct physical defect in the catheter itself.
The recalled product
- Product
- ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple…
- Manufacturer
- Arrow International Inc
- Affected units
- 23,904
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)
- CDA-45854-P1A 13F17C0325 13F17D0283 13F17F0748
Distribution
Part of a larger recall action
This product is one of 12 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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