—#50416

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K003225, K981792
Affected lot / code info: product code 2C8857: lots R06F05158, R06F22013, R06F22112;

Why it was recalled

Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.

Timeline

Recall initiated: 2007-02-16
Posted by FDA: 2007-03-14
Terminated: 2008-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.