The Recall Desk
ModerateFDA (Devices)·Z-1365-2019·Announced 2019-05-22

Arrow PICC Recall for Incorrect Length Labeling

Arrow International Inc. is recalling Arrow PICC kits because some may contain a different length than labeled.

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 the hazard involves a labeling error regarding device length. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving potential misuse or incorrect application.

Plain-English summary

Arrow International Inc. is recalling Arrow PICC powered by Arrow VPS Precision Stylet kits (Product Code: CDC-45052-VPS2) due to labeling errors. The recall involves 963 units distributed nationwide in the United States.

The hazard is that kits labeled as containing a 40 cm PICC may actually contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC. This discrepancy could lead to the use of an incorrect device length for the intended medical procedure.

Healthcare providers and consumers should stop using the affected lots (23F18F0005, 23F18B0583) and contact Arrow International Inc. for further instructions or a replacement.

The recalled product

Product
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure i
Affected units
963

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)

  • Lot /Batch Number: 23F18F0005
  • 23F18B0583 GTN:40801902120753

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →