The Recall Desk
SevereFDA (Devices)·Z-2265-2017·Announced 2017-06-14

Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk

Arrow International is recalling 43,394 units of ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits nationwide due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.

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 constitutes a significant injury report under the severity rubric.

Plain-English summary

Arrow International Inc. has initiated a nationwide recall of 43,394 units of ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits. The affected product is identified by Material Number CDA-25123-1A. These kits are designed to permit venous access to the central circulation for rapid fluid administration.

The recall was initiated due to reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle packaged with certain Arrow products. The source text does not specify the number of reported injuries or the specific dates of the incidents.

Healthcare facilities and consumers who have these specific kits should stop using them and contact Arrow International Inc. for further instructions on how to return or dispose of the product safely.

The recalled product

Product
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration
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 CDA-25123-1A

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 →