The Recall Desk
ModerateFDA (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.

What this means for you

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: multip

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: