Z-0618-2007

Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing...

Name: Z-0618-2007 Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing...
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 Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream... 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-0618-2007
Status: Terminated
Initiated: 2007-02-16
Posted: 2007-03-14
Terminated: 2008-03-17
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve, 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 2C8857
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: 480 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 2C8857: lots R06F05158, R06F22013, R06F22112;

Product code FPA

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)