Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 7.7" (20.0 cm), Vol. 1.10 mL, 1 Catheter Extension Set wit

FDA device recall Z-0354-2011 · posted 2010-11-15 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

LBJ

Quantity affected

10,000 units

Distribution

Nationwide Distribution: Throughout the US.

Date initiated

2010-09-17

Date posted

2010-11-15

Date terminated

2011-10-04

Location

Round Lake, IL