—#94560

Product

Baxter INTERLINK System, Non-DEHP Catheter Extension Set Kit; 7.1" (18.0 cm), Vol. 0.85 mL, 1 Catheter Extension Set with injection site and male luer lock adapter with retractable collar, 1 VITAL-HOLD Medium Catheter Stabilization Device, 2 foam tape strips; an Rx sterile convenience kit for IV infusions; 50 units per case; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60015 U.S.A., Made in Costa Rica; catalog 2N8221

FDA product code: LBJ — Device, Vein Stabilization
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: catalog 2N8221, lot numbers R10A25110

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution: Throughout the US.

Timeline

Recall initiated: 2010-09-17
Posted by FDA: 2010-11-15
Terminated: 2011-10-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.