Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path
Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Particulate matter found inside the fluid path."
Plain-English summary
Baxter Healthcare Corp is recalling 94,224 units of the Baxter 2B8011 Empty INTRA VIA Container with PVC Ports. These sterile fluid path containers, with a capacity of 150 ml, are intended for the preparation and administration of drug admixtures. The specific lot number is UR13D15112.
The recall was initiated because particulate matter was found inside the fluid path of the containers. This defect poses a potential risk to patients if the containers are used for drug administration.
The affected products were distributed nationwide, including Puerto Rico, and in the country of Canada. Healthcare facilities and consumers who have these specific containers should stop using them and contact Baxter Healthcare Corp for further instructions or a return.
The recalled product
- Product
- Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
- Manufacturer
- Baxter Healthcare Corp
- Affected units
- 94,224
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: 2B8011 Lot Number: UR13D15112
Distribution
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.
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