Arrow International Recalls CVC Kits Missing Lot and UDI Stickers
Arrow International Inc. is recalling 23,904 Arrowg+ard BLUE PLUS CVC Kits because some units are 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 classified as FDA Class II, but the specific defect is a missing sticker containing lot and UDI information. This is a documentation and packaging issue that does not directly cause adverse health consequences, fitting the criteria for a Low severity score.
Plain-English summary
Arrow International Inc. is recalling 23,904 units of the Arrowg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit. The recall is due to a labeling defect where some of the products are 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 include CDA-42802-P1A, CDA-42854-P1A, CDA-45703-P1A, and various 13F series codes.
Healthcare facilities and consumers should check their inventory for these specific lot codes. If a unit is found to be missing the required sticker, it should be removed from use and returned to the manufacturer or the distributor in accordance with the recall instructions.
The recalled product
- Product
- ARROWg+ard BLUE PLUS Pressure Injectable Two- 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
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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