Arrow International Recalls CVC Kits Missing Lot and UDI Information
Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a missing sticker with lot and UDI information, which is a documentation and packaging issue rather than a direct physical hazard or contamination risk.
Plain-English summary
Arrow International Inc is recalling 23,904 units of the AGB+ Pressure Injectable Quad-Lumen CVC Kit. The recall was initiated because some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
The affected products are distributed in the United States in the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. The specific code information associated with the recall is CA-45854-P1A 13F17F0071.
The Arrow CVC is indicated to provide short-term central venous access for treatment of diseases or conditions requiring central venous access. Consumers and healthcare providers should verify the presence of the required labeling stickers on their inventory and contact the manufacturer for further instructions regarding the missing information.
The recalled product
- Product
- AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluid
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 23,904
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)
- CA-45854-P1A 13F17F0071
Distribution
Part of a larger recall action
This product is one of 12 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 12 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
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
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 CP Smart Assist Set Lacks Labeling for Potential Device Interaction
FDA (Devices) · 2024-09-11
- ModerateImpella CP Smart Assist Set: Device interaction safety labeling update
FDA (Devices) · 2024-09-11
- HighImpella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
FDA (Devices) · 2024-09-11