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Z-0085-2015 Class I Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA device recall Z-0085-2015 was initiated by Baxter Healthcare Corp on Sep 16, 2014 and is designated Class I. Reason for recall: Particulate matter found inside the fluid path. The recall status is terminated (terminated Jun 21, 2017). Affected quantity: 20448.

Recall Details

Product Type: Devices
Report Date: Nov 12, 2014
Initiation Date: Sep 16, 2014
Termination Date: Jun 21, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20448

Product Description

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.

Reason for Recall

Particulate matter found inside the fluid path.

Distribution Pattern

Nationwide Distribution including Puerto Rico, and the country of Canada.

Code Information

Product code 2B8013 Lot Number: UR13K14095

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0085-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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