The Recall Desk
SevereFDA (Devices)·Z-2279-2017·Announced 2017-06-14

Arrow International Recalls CVC Kits Due to Needlestick Injury Risk

Arrow International is recalling specific CVC kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk to medical personnel.

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 involves a Class II medical device with reported needlestick injuries, which aligns with the rubric criteria for significant injury reports.

Plain-English summary

Arrow International is recalling the AGB+ Pressure Injectable Multi-Lumen CVC Kit. The recall is initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle that is packaged with certain Arrow products.

The affected products are intended to permit venous access to the central circulation. The recall is limited to the specific material number CDA-42703-P1A. The products were distributed nationwide.

Healthcare facilities should stop using the affected kits and contact Arrow International for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by wa

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 CDA-42703-P1A

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 →