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Terminated

Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

FDA Recall Z-0485-2018 · Posted 2018-01-11

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKPE
Date Initiated2017-07-27
Date Terminated2020-11-03
Product Quantity29,088 units

Reason for Recall

A leak may allow for microbial contamination of the sterile fluid path.

Firm Action

US consignees were notified via letter on July 27, 2017 and Canadian consignees were notified on July 31, 2017. Instructions included to locate and remove all affected product from the facility, contact Baxter Healthcare to arrange for return of product, complete and return the Reply Form, and to notify customers if the product was further distributed. For further questions, please call (800) 422-9837.

Root Cause

Process control

Distribution Pattern

Distribution in the US and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964853INTRAVIA CONTAINER, EMPTYBaxter Healthcare Corp · 1997-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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