The Recall Desk
HighFDA (Devices)·Z-0085-2015·Announced 2014-11-12

Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.

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 contamination hazard (particulate matter) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Baxter Healthcare Corp is recalling 20,448 units of Baxter 2B8013 Empty INTRA VIA Containers with PVC Ports. These 500 ml sterile, nonpyrogenic fluid path containers are intended for the preparation and administration of drug admixtures. The specific lot number is UR13K14095.

The recall was initiated because particulate matter was found inside the fluid path of the containers. The product was distributed nationwide, including Puerto Rico, and in the country of Canada.

Consumers and healthcare facilities should stop using the affected containers and contact Baxter Healthcare Corp for further instructions or a return.

The recalled product

Product
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Affected units
20,448

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)

  • Product code 2B8013 Lot Number: UR13K14095

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corp 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 2 products in this recall →