The Recall Desk
SevereFDA (Devices)·Z-2260-2017·Announced 2017-06-14

Arrow International Recalls Hemodialysis Catheter Kits Due to Needlestick Risk

Arrow International is recalling 43,394 hemodialysis catheterization kits nationwide 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 involves reported needlestick injuries, which constitute significant injury reports, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Arrow International Inc. is recalling 43,394 units of the Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter. The affected product, identified by Material Number ASK-22122-MM, was distributed nationwide.

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 device is a multi-lumen central venous access device intended for venous access and catheter introduction to the central circulation.

Healthcare facilities and consumers should stop using the affected kits and contact Arrow International for further instructions or replacement.

The recalled product

Product
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and
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 NumberASK-22122-MM

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 →