The Recall Desk
SevereFDA (Devices)·Z-1879-2017·Announced 2017-05-03

Arrow International Recalls Central Venous Catheter Kits Due to Hub Voids

Arrow International is recalling 310 units of Arrowg+ard Blue Plus Central Venous Catheterization Kits due to possible voids in the catheter hub that could lead to interlumen crossover.

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 agency classifies this as a Class II recall, and the defect (interlumen crossover in a central venous catheter) poses a significant risk of injury or serious health consequences, fitting the 'Severe' criteria for significant injury reports or high-risk medical device defects.

Plain-English summary

Arrow International Inc is recalling 310 units of the Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. The recall is due to possible voids in the catheter hub, which could lead to an interlumen crossover. The product is intended to provide venous access to central circulation and protection against catheter-related bloodstream infections.

The affected product codes are ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM. The specific lot numbers involved are 13F16L0105, 23F16K0180, and 13F16L0199. The agency classifies this recall as Class II.

The product was distributed in the United States to New Jersey, Illinois, and Pennsylvania. Healthcare facilities and consumers should check their inventory for these specific product codes and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream
Manufacturer
Arrow International Inc
Category
Medical Device — Central Venous Catheter
Hazard
Affected units
310

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 (4)

  • Product Codes ASK-45703-PRWJ1
  • ASK-45703-PUAB1
  • and ASK-45703-PUPM Lot # 13F16L0105
  • 23F16K0180 and 13F16L0199

Distribution

Distributed in 3 states:

Related recalls

Same manufacturer · Arrow International Inc

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