The Recall Desk
LowFDA (Devices)·Z-1162-2018·Announced 2018-03-28

Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical safety checklists.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to missing documentation (checklists) rather than a physical defect or contamination, which aligns with the 'documentation issues' criterion for a Low severity score.

Plain-English summary

Arrow International Inc is recalling 18,124 units of the Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. The products were distributed nationwide.

The recall was initiated because the kits do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist. These documents are intended to guide clinicians in using best practices during central line insertions.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.

The recalled product

Product
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Affected units
18,124

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)

  • ASK-45703-PNCB 23F16H0802

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 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 9 products in this recall →