Class 2 Device Recall Baxter Clearlink IV Administration & Extension Sets

• Date Initiated by Firm: February 28, 2005
• Date Posted: May 17, 2005
• Recall Status: Terminated on February 08, 2007
• Recall Number: Z-0845-05
• Recall Event ID: 31245
• 510(K)Number: K003225 K791496 K961225 K962581 K984381
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
• Code Information: Product code 2C6255, lot R04J12126; Product code 2C8428, lot R04J11318; Product code 2C8515, lot R04J12043; Product code 2C8519, lots R04J12076, R04J12159; Product code 2C8537, lots R04J11128, R04J11201, R04J12027, R04J12084, R04J12183, R04J13033, R04J13116, R04J13173, R04J14031, R04J14098, R04J14130, R04J14155, R04J15061; Product code 2C8546, lot R04J11177; Product code 2C8571, lot R04J14205; Product code 2C8606, lot R04J13025; Product code 2C8612, lot R04J12019; Product code 2C8632, lot R04J12258; Product code 2C8634, lot R04J13090; Product code 2C8819, lots UR241323, UR242560, UR242669; Product code 2C8864, lot UR240697; Product code 2C8865, lots UR241638, UR241786, UR244012; Product code A2C9801, lots UR244020, UR245647; Product code 2H8401, lot R04J12068; Product code 2H8519, lots R04J15053, R04J16010; Product code 2N8371, lot UR245027; Product code 2N8373, lot UR243501; Product code 2N8374, lots UR229138, UR229526, UR230193, UR230193X, UR230433, UR230458, UR240747, UR241059, UR241356, UR241505, UR242065, UR246033; Product code 2N8378, lots UR229344, UR229781, UR230060, UR241133, UR241661, UR242107, UR242131, UR242362, UR242644, UR244632; Product code 2N8399, lots UR230128, UR230573, UR231027, UR231704, UR239301, UR239889, UR240200, UR240945, UR241265, UR242081, UR242230, UR243576
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
• FDA Determined Cause: Other
• Action: Recall letters dated 2/28/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Nursing. The accounts were informed of the increase in reports of ClearLink valve occlusion, requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit. The letters included a copy of the Technical Letter revised 5/4/04, outlining the correct preparation and use ClearLink valve product, including detecting valve re-knits.
• Quantity in Commerce: 1,171,116 sets
• Distribution: Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Panama, Australia, New Zealand and Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA; 510(K)s with Product Code = FPA