Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information
Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.
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: The recall is classified as FDA Class II, and the hazard involves missing documentation (lot number, expiration date, UDI) rather than a direct physical defect or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Arrow International Inc is recalling 420 units of the ARROWg+ard Blue PLUS catheter, Catalog Number ASK-45854-NG. The recall affects specific lots distributed in Florida, United States. The affected lot numbers are 23F16H0744, 23F16J0072, and 23F17B0781.
The recall was initiated because certain lots may be missing critical information at the bottom of the lid, including the lot number, expiration date, and Unique Device Identification (UDI) information. The ARROWg+ard Blue PLUS catheter is intended to provide venous access to central circulation and protection against catheter-related bloodstream infections, but it is not indicated for long-term use exceeding 30 days.
Healthcare providers and facilities that have received these specific lots should stop using the affected products and contact Arrow International Inc for further instructions. Consumers should not use these devices if they are found in a home setting and should contact their healthcare provider for guidance.
The recalled product
- Product
- ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Affected units
- 420
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 (3)
- Lot Numbers: 23F16H0744
- 23F16J0072
- 23F17B0781
Distribution
Distributed in 1 state:
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 · missing labeling
See all →- ModerateBadger 50 Mineral Sunscreen Recalled for Missing Drug Facts Labeling
FDA (Drugs) · 2025-02-05
- HighSour Charlie bread recalled for undeclared wheat allergen
FDA (Food) · 2024-10-30
- HighImpella 5.5 Pump Labeling Updated Due to Device Interaction
FDA (Devices) · 2024-09-11
- HighImpella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
FDA (Devices) · 2024-09-11
- HighImpella CP Smart Assist Set Lacks Labeling for Potential Device Interaction
FDA (Devices) · 2024-09-11
Similar recalls
- LowArrow International Recalls Arrowg+ard Blue Catheters Due to Missing Labels
FDA (Devices) · 2018-03-21
- SevereArrow International Recalls Central Venous Catheter Kits Due to Hub Voids
FDA (Devices) · 2017-05-03
- HighArrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateArrow CVC Kit Recall for Missing Lot and UDI Stickers
FDA (Devices) · 2018-03-21
- ModerateArrow Central Venous Catheter Kits Recalled for Missing Label Information
FDA (Devices) · 2018-03-21
- LowArrow International Recalls Central Venous Catheter Kits Due to Missing Labels
FDA (Devices) · 2018-03-21