The Recall Desk
ModerateFDA (Devices)·Z-1965-2013·Announced 2013-08-21

Arrow International Recalls Two-Lumen CVC Kits Due to Labeling Error

Arrow International is recalling 156 Two-Lumen CVC Kits because a portion of the packaging incorrectly identifies the catheter as 3-Lumen.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding the number of lumens, which fits the rubric for moderate severity involving labeling issues without reported injuries.

Plain-English summary

Arrow International, Inc. is recalling 156 units of its Two-Lumen CVC Kit with Blue Flex Tip Catheter. The recall is due to a labeling inconsistency on the product packaging. Specifically, one portion of the lidstock states that the kit contains a 3-Lumen catheter, while the rest of the lidstock correctly identifies the catheter as 2-Lumen.

The affected products are identified by Catalog # AK-17702-CDC and Lot # RF2083258. These kits were distributed to facilities in Alabama, Pennsylvania, Connecticut, North Carolina, Virginia, Kansas, Rhode Island, Arizona, New Jersey, and Illinois.

Healthcare providers and consumers should check their inventory for this specific lot and catalog number. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with standard recall procedures.

The recalled product

Product
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Affected units
156

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 (2)

  • Catalog # AK-17702-CDC
  • lot # RF2083258

Distribution

Distributed in 10 states: