Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2136-2016·Announced 2016-07-13

Arrow Recalls Central Venous Catheters Due to Length Mismatch

Arrow International Inc. is recalling specific lots of central venous catheters because kits labeled for 20 cm catheters may contain 16 cm catheters.

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 a labeling/packaging error (length mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Arrow International Inc. is recalling specific lots of ARROW, ARROWG+ARD, and ARROWG+ARD BLUE PLUS Pressure Injectable Central Venous Catheters. The recall is due to a labeling discrepancy where kits labeled as containing a 20 cm catheter may actually contain a 16 cm catheter.

The affected products are indicated for short-term central venous access. The recall involves 1,170 units distributed nationwide in the states of Massachusetts, California, Illinois, and Tennessee. Specific lot numbers and product codes are listed in the official FDA record.

Healthcare providers and consumers should check their inventory for the specific lot numbers and product codes identified in the recall notice. If a device is found to be affected, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to…
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
Hazard: mis-labeling
packaging-error

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 (12)

Device Listing # D040746
FDA Product Code FOZ
Product Code: ASK-45854-PUC
ASK-45854-PSFM
ASK-42854-PCSM and ASK-42854-PBW4 Lot # 23F15F1786
23F15F1862
23F15G0818
23F15J0162
23F15H0460
23F15F0943
23F15G0729
23F15J1084

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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 · mis labeling