The Recall Desk
ModerateFDA (Devices)·Z-2772-2016·Announced 2016-09-21

Arrow Select Kit Ultrasound Catheters Recalled for Packaging Molding Abnormality

Arrow International Inc. is recalling 6,121 units of Arrow Select Kit ultrasound catheters due to a component molding abnormality in the packaging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a packaging molding abnormality without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Arrow International Inc. is recalling 6,121 units of Arrow Select Kit (ASK) ultrasound intravascular catheters. The recall was initiated due to a notification from a supplier regarding a component molding abnormality used to package these products. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

The affected products were distributed in the United States to the states of North Carolina, Ohio, Florida, and Maryland. Specific lot numbers are listed in the recall documentation.

Consumers and healthcare facilities should stop using the affected products and contact Arrow International Inc. for further instructions or a replacement.

The recalled product

Product
Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Affected units
6,121

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 (20)

  • Lot/Batch Numbers: 23F15L0662
  • 23F15J0260
  • 23F15K0983
  • 23F15G0159
  • 23F15J1102
  • 23F15J0259 23F15C1225
  • 23S15G0973
  • 23F15H1033
  • 23F15F0358
  • 23F15K0345
  • 23F15D1514 23F15C1226
  • 23F15H0919
  • 23F15E1091
  • 23F15H0014
  • 23F15D0241
  • 23F15J0533 23F15E1094
  • 23F15H0020
  • 23F15H0740
  • 23F15K1009
  • 23F15J0431

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →