The Recall Desk
HighFDA (Devices)·Z-2271-2017·Announced 2017-06-14

Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

What this means for you

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 risk-of-harm product (needlestick injury) where the hazard is explicitly named, but the source text does not report specific fatalities or serious injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Arrow International Inc. has initiated a recall of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter. The recall is driven by reports that the safety cover on the BD Eclipse Needle, which is packaged with certain Arrow products, may disengage. This defect creates a risk of needlestick injury for healthcare professionals handling the device.

The affected product is the ARROWg+ard Blue Plus" antimicrobial catheter, indicated for short-term central venous access. The specific material number for the recalled items is ASK-15703-PST. The firm reports that a total of 43,394 devices were distributed nationwide.

Healthcare facilities and consumers should stop using the affected catheter kits immediately. Users should contact Arrow International Inc. for instructions on how to return the product or obtain a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not li
Affected units
43,394

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 (1)

  • Material Number ASK-15703-PST

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 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 56 products in this recall →