Arrow International Recalls Certain Lots of Central Venous Catheter Kits
Arrow International is recalling specific lots of central venous catheter kits because they may not be completely sealed, preventing a guarantee of sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be guaranteed, posing a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling certain lots of AGB+ and ARROWg+ard central venous catheterization (CVC) kits. The recall covers various multi-lumen, pressure injectable, and quad-lumen kits, including specific part numbers and lot numbers listed in the agency's official notice.
The recall was initiated because the cardiovascular catheters in these kits may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. The affected products were distributed in all 50 U.S. states, the District of Columbia, and in the Bahamas, Canada, Mexico, Panama, and Singapore.
Healthcare facilities and consumers should check their inventory for the specific part numbers and lot numbers identified in the recall. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7)…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
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 (20)
- Lot Numbers: (1) 13F17A0135
- 13F17C0355
- 13F17E0212
- 13F17E0789
- 13F17F0386
- (2) 13F17A0028
- 13F17E0044
- 13F17E0448
- (3) 13F17B0118
- 13F17F0385
- (4) 13F17B0152
- 13F17C0057
- (5) 13F17F0226
- (6) 13F17A0157
- 13F17B0117
- 13F17C0250
- (7) 13F17F0071
- (8) 13F17A0022
- 13F17A0301
- 13F17C0266
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 14 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 14 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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateArrow Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2017-06-21
- ModerateArrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
FDA (Devices) · 2018-06-06
- HighArrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateArrow International Recalls Central Venous Catheterization Kits Due to Packaging Issues
FDA (Devices) · 2018-06-06
- ModerateArrow International Recalls Multi-Lumen Central Venous Catheterization Kits
FDA (Devices) · 2018-06-06
- HighArrow International Recalls Central Venous Catheter Kits Due to Packaging Defect
FDA (Devices) · 2018-06-06