The Recall Desk
ModerateFDA (Devices)·Z-2774-2016·Announced 2016-09-21

Arrow Select Kit Recall Due to Component Molding Abnormality

Arrow International Inc. is recalling 6,121 Arrow Select Kit units due to a component molding abnormality reported by a supplier.

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 does not report any illnesses, injuries, or deaths, 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) products. The recall was initiated following a notification from a supplier regarding a component molding abnormality used in the packaging of these products.

The affected products are Arrow Select Kits, which are indicated to provide short-term central venous access for less than 30 days. The recall covers specific lot numbers distributed to North Carolina, Ohio, Florida, and Maryland.

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

The recalled product

Product
Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
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 →