Recall Z-0366-2019— Baxter Healthcare Corporation

Name: FDA recall Z-0366-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-12

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2018-09-12, terminated 2020-11-02. It names one FDA 510(k) clearance: K900585. Product: EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.. Reason: Potential ability to leak once used for compounding..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-09-12
Terminated: 2020-11-02
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K900585 — TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPBaxa Corp., Sub. of Cook Group, Inc.·cleared 1990-04-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

Reason for recall

Potential ability to leak once used for compounding.

Data sourced from openFDA. This site is unofficial and independent of the FDA.