Arrow International Recalls CVC Kits Missing Lot Number Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, 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 Low severity because the hazard is limited to missing documentation (lot number, expiration date, and UDI stickers), which is a packaging and documentation issue rather than a direct physical or chemical defect in the device itself.
Plain-English summary
Arrow International Inc is recalling 23,904 units of the AGB+ Pressure Injectable Multi-Lumen CVC Kit. The recall is due to a documentation issue where 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 are 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 this recall include CA-42703-P1A and several 13F series codes.
Consumers and healthcare facilities should check their inventory for these specific lot codes and verify that the required stickers are present. If the stickers are missing, the products should be removed from use and returned to the manufacturer or supplier in accordance with recall instructions.
The recalled product
- Product
- AGB+ Pressure Injectable 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
- Hazard
- 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.
See all 12 products in this recall →Related recalls
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