The Recall Desk
ModerateFDA (Devices)·Z-2590-2023·Announced 2023-09-27

Arrow ErgoPack PICC Catheters Recalled for Incorrect Product Labeling

Arrow International is recalling 190 units of Arrow ErgoPack One-Lumen PICC catheters (Lot 13F22J0617) because the product code and product name were incorrectly printed on the kit packaging. The units were distributed nationwide.

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: This is an FDA Class II recall for a labeling error where the product code and product name were incorrectly listed on the packaging. The defect is documentation-related rather than a physical defect in the device itself. Per the severity rubric, minor labeling errors are classified as Score 2 (Moderate).

Plain-English summary

Arrow International Inc. is recalling 190 units of the Arrow ErgoPack Pressure Injectable One-Lumen PICC (Reference CDC-05541-HPK1A), Lot 13F22J0617. The product code and product name were incorrectly listed on the lidstock of the affected kits.

All affected units are from Lot 13F22J0617 and were distributed nationwide in the United States. The FDA has classified this as a Class II recall.

Healthcare providers and patients with affected kits should verify the product identification and contact Arrow International with any questions.

The recalled product

Product
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Intravascular Catheter
Hazard
  • mis-labeling

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 13F22J0617

Distribution

Distributed nationwide across the United States.

Related recalls

Same category