The Recall Desk
SevereFDA (Devices)·Z-2254-2017·Announced 2017-06-14

Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

Arrow International is recalling specific central venous access kits because the packaged BD Eclipse Needle has a safety cover that 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 involves reported needlestick injuries, which constitute significant injury reports, meeting the criteria for a Severe (Score 4) classification under the rubric.

Plain-English summary

Arrow International Inc. has initiated a recall of the ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters. 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 devices are intended for venous access and catheter introduction to the central circulation via the jugular, subclavian, or femoral veins. The recall number is Z-2254-2017, and the agency classification is Class II. The source text indicates that 43,394 units were distributed nationwide.

Healthcare providers and facilities should stop using the affected kits and contact Arrow International for further instructions on how to handle the recalled products.

The recalled product

Product
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the
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 (2)

  • 510K # K002507
  • Material # ASK-21142-HF3

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 →