Baxter CLEARLINK System, NonDEHP Catheter Extension Set Kit 의 리콜

Recall

56792

Class 3

Z-0356-2011

2010-09-17

2010-11-15

Terminated

United States

2011-10-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94561

The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. the device is labeled as nonpyrogenic.

Baxter issued Urgent Product Recall letters dated September 17, 2010 to the affected direct accounts. The accounts were informed that the paper lining covering the adhesive strip that is used to secure the catheter stabilization device to the patient was found to be pyrogenic. The accounts were requested to discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts. Clinical questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303. Any other questions may be directed to the Center for One Baxter at 1-800-422-9837.