The Recall Desk
LowFDA (Devices)·Z-1002-2018·Announced 2018-03-21

Arrow International Recalls Arrowg+ard Blue Catheters Due to Missing Labels

Arrow International Inc. is recalling 23,904 Arrowg+ard Blue central venous catheters because some units are missing stickers with lot, expiration, 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 classified as FDA Class II, but the specific defect is a missing label (documentation issue) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging/documentation problems.

Plain-English summary

Arrow International Inc. is recalling 23,904 units of Arrowg+ard Blue central venous catheters. 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. Specific lot codes associated with the recall include CDA-29803-1A, 13F16M0122, 13F17C0267, 13F17E0385, and 13F17G0192.

Healthcare providers and consumers should check their inventory for these specific lot codes and verify that the required labeling stickers are present. If the stickers are missing, the products should be removed from use and returned to the manufacturer or supplier according to recall instructions.

The recalled product

Product
ARROWg+ard Blue 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 fluids, medications, or chemothera
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-29803-1A 13F16M0122 13F17C0267 13F17E0385 13F17G0192

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 →