Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump seg
FDA device recall Z-0619-2007 · posted 2007-03-14 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 15,097 units
- Distribution
- Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.
- Date initiated
- 2007-02-16
- Date posted
- 2007-03-14
- Date terminated
- 2008-03-17
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLUTION ADMINISTRATION SET (K981792) | Baxter Healthcare Corp | 1998-08-17 |