Z-0620-2007

Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment...

Name: Z-0620-2007 Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment...
Creator: Baxter Healthcare Corp.
Published: 2007-02-16
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2007-02-16 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter... on 2007-02-16. The reason FDA records is "Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0620-2007
Status: Terminated
Initiated: 2007-02-16
Posted: 2007-03-14
Terminated: 2008-03-17
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C7553
Product code: FPA Set, Administration, Intravascular
Reason for recall: Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
FDA root cause: Other
Action: Baxter sent the 2/16/07 Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential disconnections/leaks during use of the Vented Paclitaxel Administration Sets. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 200,309 units
Distribution: Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.
Product codes and lots: product code 2C7553, lots R06E13105, R06E17114, R06E25042, R06F15058, R06G11030, R06I13107, R06K03071

Product code FPA

K981792Class IISolution Administration SetBaxter Healthcare Corp / cleared 1998-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)