The Recall Desk
HighFDA (Devices)·Z-2274-2017·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 medical device with reported needlestick injuries, which constitutes a risk-of-harm product where injury has been reported but does not meet the criteria for FDA Class I or severe structural defects.

Plain-English summary

Arrow International Inc. has initiated a recall of the Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The recall is limited to units with material number ASK-42802-PHF2 that were distributed nationwide.

The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle packaged with these Arrow products. The catheter is indicated for short-term central venous access.

Healthcare facilities and consumers should stop using the affected kits and contact Arrow International for further instructions on how to return or dispose of the product.

The recalled product

Product
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit 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 limited to

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-42802-PHF2

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 →