Arrow International Recalls CVC Kits Missing Lot Number Stickers
Arrow International is recalling 23,904 Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kits because some units may be missing stickers containing lot numbers, expiration dates, 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and packaging issue (missing stickers) with no reported injuries or illnesses, fitting the 'Low' severity criteria for cosmetic or documentation defects.
Plain-English summary
Arrow International Inc is recalling 23,904 units of the Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kit. The recall is due to a labeling defect where some products may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
The affected products are indicated for short-term central venous access. The recall covers units distributed in the United States in the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. The specific product code is CDA-22123-1A 13F17F0744.
Healthcare providers and consumers should check their inventory for these specific kits. If a unit is missing the sticker with the lot number, expiration date, and UDI, it should be removed from use and returned to the manufacturer or supplier for replacement or credit.
The recalled product
- Product
- ARROWg+ard Blue¿ Large-Bore Multi-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 infusions of…
- 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-22123-1A 13F17F0744
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.
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