The Recall Desk
SevereFDA (Devices)·Z-0003-2024·Announced 2023-10-11

Arrow Central Venous Catheter Recalled for Incorrect Lidstock Labeling

Arrow International is recalling 380 units of its Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) due to incorrect product code and name listed on the package lidstock.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA Class I classification requires a minimum severity score of 4 per the assessment rubric. No illnesses or injuries have been reported; however, the labeling error on a medical device creates potential for device misidentification and clinical misuse.

Plain-English summary

Arrow International Inc. is recalling 380 units of the Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) distributed in the United States.

The recall was initiated following reports that the product code and product name were incorrectly listed on the lidstock of the affected kits.

The recalled product

Product
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Manufacturer
ARROW INTERNATIONAL Inc.
Hazard
  • labeling-error

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)

  • Batch/Lot number 13F22L0806

Distribution

Distribution scope not specified by the agency.