Baxter Recalls 500mL IntraVia Containers Due to Potential Sterility Leak
Baxter Healthcare is recalling 29,088 units of 500mL IntraVia containers in the US and Canada because a leak may allow microbial contamination of the sterile fluid path.
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 3/5 (High).
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 risk of microbial contamination in a sterile medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 29,088 units of Empty IntraVia Container with Non-DEHP Fluid Path, 500mL. These containers are intended for the preparation and administration of drug admixtures. The specific product code is 2J8003 and the lot number is DR16J18096.
The recall is being issued because a leak may allow for microbial contamination of the sterile fluid path. The affected units were distributed in the United States and Canada.
Healthcare providers and facilities should stop using the affected containers and contact Baxter Healthcare Corporation for further instructions or a return.
The recalled product
- Product
- Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 29,088
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 Code 2J8003
- Lot No. DR16J18096.
Distribution
Distribution scope not specified by the agency.
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