Agency classClass IIOur severity:High FDA (Devices)·Z-1335-2018·Announced 2018-04-18

Arrow International Recalls Certain Lots of AGB+ Multi-Lumen CVC Kits

Arrow International is recalling specific lots of AGB+ central venous catheter kits because the seals may be incomplete, 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, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Arrow International Inc. is recalling certain lots of AGB+ Multi Lumen, Quad-Lumen, and Two-Lumen Central Venous Catheter (CVC) Kits. The recall includes specific part numbers and lot numbers identified in the agency's structured data. The products were distributed in all 50 U.S. states, the District of Columbia, and in the Bahamas, Canada, Mexico, Panama, and Singapore.

The recall is being conducted because certain lots of the cardiovascular catheters may not be completely sealed. As a result, the sterility of the product cannot be guaranteed. This defect poses a risk of infection if the non-sterile product is used in a clinical setting.

Healthcare facilities and consumers should stop using the affected lots immediately. Users should check their inventory against the specific part numbers and lot numbers listed in the official recall notice to identify affected units.

The recalled product

Product: AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A…
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
Hazard: infection
sterility-failure

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) 13F17F0049
(2) 13F17B0224
13F17E0142
13F17E0830
(3) 13F16L0220
(4) 13F17E0463
13F17F0169
(5) 13F17E0685
(6) 13F17D0275
13F17D0325
(7) 13F17C0470
13F17D0243
(8) 13F17E0358
(9) 13F17B0031
13F17E0626
(10) 13F17B0035
13F17E0627
(11) 13F17B0135
13F17D0191
(12) 13F16M0173

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 →

Same manufacturer · Arrow International Inc

See all →

High
Arrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
Severe
Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
Severe
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
Severe
Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
Severe
ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27

Same hazard · infection