The Recall Desk
SevereFDA (Devices)·Z-2267-2017·Announced 2017-06-14

Arrow International Recalls Central Catheters Due to Needlestick Injury Risk

Arrow International is recalling 43,394 units of central catheters 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 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 the Pressure injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product, specifically Material Number CDC-41541-JX1A. The recall is being conducted under FDA recall number Z-2267-2017.

The recall was 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 product is a medical device designed to permit venous access to the central circulation through a central vein.

Healthcare facilities and distributors should stop using the affected units and contact Arrow International Inc. for further instructions on the return or disposal of the recalled product.

The recalled product

Product
Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
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 CDC-41541-JX1A

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 →