The Recall Desk
HighFDA (Devices)·Z-1082-2015·Announced 2015-02-18

Arrow International Recalls Two-Lumen CVC Kits Due to Foreign Material

Arrow International Inc is recalling 1,195 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because visible foreign material was found inside the kits.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm from foreign material, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc is recalling 1,195 units of the ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The recall is due to the discovery of foreign material within the kits. The foreign material consists of white or black particles and/or thread, which is visible and can be identified by the user.

The affected product is identified by product number CDC-42802-P1A and lot number 23F14A0063. The kits were distributed nationwide. The Multiple-Lumen Catheter is designed to permit venous access to the central circulation via the femoral, jugular, or subclavian veins.

Healthcare facilities and users should check their inventory for the specific product number and lot number listed above. 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
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Affected units
1,195

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 (2)

  • product number CDC-42802-P1A
  • lot number 23F14A0063

Distribution

Distributed nationwide across the United States.