The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2330-2017·Announced 2017-06-21

Arrow Recalls Central Venous Catheter Kits Due to Sterility Concerns

Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 hazard is a potential sterility compromise due to packaging issues. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Arrow International is recalling specific Pressure Injectable Multi-Lumen Central Venous Catheterization Kits. The recall is being conducted because the packaging for these devices may not be completely sealed. This defect may compromise the sterility of the catheters.

The affected products include various configurations of the Arrow CVC, such as kits with Blue FlexTip(R) Catheter and Sharps Safety Features, and kits with ARROWg+ard Blue Plus (R) Catheter. The devices are indicated to provide short-term central venous access for less than 30 days.

A total of 27,485 units were distributed in the United States and 4,371 units were distributed internationally. The distribution pattern is listed as worldwide, including the US (nationwide) and Canada. The recall is classified as Class II by the FDA.

The recalled product

Product
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue…
Manufacturer
Arrow International Inc
Category
Medical Device — Central Venous Catheter
Hazard

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 (14)

  • Material number: ASK-12703-PLV1
  • ASK-15703-PLV
  • ASK-15703-PRH
  • ASK-42703-PRJ
  • ASK-45703-PRH
  • ASK-45703-PRWJ1
  • AK-42703-P1A
  • AK-45703-P1A
  • CA-42703-P1A
  • CA-45703-P1A
  • CDA-42703-P1A
  • CDA-42802-P1A
  • CDA-45703-P1A
  • Device Listing D040746

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

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