The Recall Desk
LowFDA (Devices)·Z-1001-2018·Announced 2018-03-21

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.

What this means for you

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 fl
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

Distributed in 7 states:

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 →