Arrow International Recalls CVC Kits Missing UDI Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (missing stickers) rather than a functional defect or contamination, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Arrow International Inc is recalling 23,904 units of the AGB+ Pressure Injectable Multi-Lumen CVC Kit. The recall is due to a documentation issue where some of the products may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
The affected products were distributed in the United States in the states of Ohio, Florida, South Carolina, Texas, Kentucky, New Jersey, and Michigan. The specific lot codes associated with the recall are CDA-42703-P1A, 13F16L0092, 13F17A0022, 13F17A0301, 13F17C0266, 13F17D0039, 13F17F0299, and 13F17H0071.
Healthcare providers and facilities should check their inventory for these specific lot codes and verify that the required stickers are present. If a product is missing the sticker with the lot number, expiration date, or UDI, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- AGB+ Pressure Injectable Multi- 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…
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 23,904
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
- 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 · documentation issue
See all →- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- SevereBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18
Similar recalls
- ModerateArrow International Recalls Central Venous Catheter Kits Missing Safety Checklists
FDA (Devices) · 2018-03-28
- ModerateArrow Multi-Lumen CVC Kit Recalled for Expired Product Documentation Error
FDA (Devices) · 2018-11-07
- HighArrow International Recalls Certain Lots of Central Venous Catheter Kits
FDA (Devices) · 2018-04-18
- HighArrow International Recalls Certain Lots of AGB+ Multi-Lumen CVC Kits
FDA (Devices) · 2018-04-18
- HighArrow International Recalls ARROWg+ard Blue CVC Kits for Central Venous Access
FDA (Devices) · 2017-06-21
- ModerateArrow International Recalls Central Venous Catheters With Incorrect Guide
FDA (Devices) · 2018-02-28