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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Hazard
- Affected units
- 190
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.
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 →Related recalls
Same manufacturer · ARROW INTERNATIONAL Inc.
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · mis labeling
See all →- ModerateEl Ruisenor De Mexico Recalls Soybeans for Undeclared Soy Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Textured Soy Protein for Undeclared Soy
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Black Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Wheat Bran for Undeclared Wheat Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
Similar recalls
- SevereArrow PICC Catheters Recalled for Incorrect Product Label Information
FDA (Devices) · 2023-10-11
- SevereFDA Recalls Arrow PICC Catheters with Incorrect Product Code Labels
FDA (Devices) · 2023-10-11
- SevereArrow ErgoPack central venous catheter recalled for incorrect labeling
FDA (Devices) · 2023-10-11
- ModerateArrow PICC Catheter Recall Due to Incorrect Component Kits
FDA (Devices) · 2018-02-21
- ModerateArrow Pressure Injectable PICC Catheter Recall Due to Incorrect Length
FDA (Devices) · 2014-04-30
- ModerateArrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion
FDA (Devices) · 2018-09-26