Baxter Interlink System Vented Paclitaxel Set recallZ-0619-2007 · Baxter Healthcare Corp. · initiated Feb 16, 2007
Terminated All recalls posted in March 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0619-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 16, 2007
- Posted by the FDA
- Mar 14, 2007
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 15,097 units
- Product code
- FPA
- FDA submissions
- K981792
- Distribution
- Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.
Product description
Baxter Interlink System 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 2C7557
Code information (models, lots, serial numbers)
product code 2C7557, lots R06I12067, R06J07025, R06J19079, R06J20044;
Other devices under the same FDA submission
4 devices cleared under K981792 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CLEARLINK 2C8858Baxter Healthcare Corporation · Set, administration, intravascular80 reports
- INTERLINK 2C7558Baxter Healthcare Corporation · Set, administration, intravascular30 reports
- CLEARLINK 2C8857Baxter Healthcare Corporation · Set, administration, intravascular18 reports
- INTERLINK 2C7557Baxter Healthcare Corporation · Set, administration, intravascular10 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 37362).
- Z-0618-2007 · TerminatedBaxter 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, L…
- Z-0620-2007 · TerminatedBaxter 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 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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