The Recall Desk
HighFDA (Devices)·Z-2305-2017·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 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 injury has been reported, but the source does not specify FDA Class I or report fatalities, fitting the High severity criteria.

Plain-English summary

Arrow International Inc. has initiated a recall of the ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The recall is driven by reports of safety cover disengagement and needlestick injuries associated with the BD Eclipse Needle that is packaged with certain Arrow products.

The affected product is indicated for short-term central venous access. The specific material number for the recalled items is ASK-46702-AH. The firm reports that a total of 43,394 devices were distributed nationwide.

Healthcare providers and consumers should stop using the affected kits and contact Arrow International for further instructions or replacement.

The recalled product

Product
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions o
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-46702-AH

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 →