The Recall Desk
SevereFDA (Devices)·Z-2273-2017·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

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reports of needlestick injury, which aligns with the rubric criteria for a Severe rating involving significant injury reports.

Plain-English summary

Arrow International Inc. has initiated a recall for the Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The recall is limited to units with material number ASK-42802-PHF1.

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 agency has classified this as a Class II recall.

The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected kits and contact Arrow International for further instructions on the recall.

The recalled product

Product
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment

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-PHF1

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 →